U.S. patent application number 12/945801 was filed with the patent office on 2011-06-23 for expandable iliac sheath and method of use.
This patent application is currently assigned to ONSET MEDICAL CORPORATION. Invention is credited to Joseph Bishop, Jay Lenker, Edward J. Nance.
Application Number | 20110152763 12/945801 |
Document ID | / |
Family ID | 44834757 |
Filed Date | 2011-06-23 |
United States Patent
Application |
20110152763 |
Kind Code |
A1 |
Bishop; Joseph ; et
al. |
June 23, 2011 |
EXPANDABLE ILIAC SHEATH AND METHOD OF USE
Abstract
Disclosed is an expandable transluminal sheath, for introduction
into the body while in a first, collapsed cross-sectional
configuration, subsequent expansion of at least a part of the
distal end of the sheath to a second, enlarged cross-sectional
configuration, and subsequent removal in a third, collapsed
cross-sectional configuration. The sheath is configured for use in
the vascular system and has utility in the introduction and removal
of implant delivery catheters. The access route is through the
femoral arteries and the iliac arteries into the aorta. The distal
end of the sheath is maintained in the first, collapsed
cross-sectional configuration during advancement to the arteries
into the aorta. The distal end of the sheath is then expanded using
a radial dilatation device, which is removed prior to the
introduction of implant delivery catheters. The distal end of the
sheath is subsequently reduced to a diametrically small size for
removal.
Inventors: |
Bishop; Joseph; (Menifee,
CA) ; Lenker; Jay; (Laguna Beach, CA) ; Nance;
Edward J.; (Corona, CA) |
Assignee: |
ONSET MEDICAL CORPORATION
IRVINE
CA
|
Family ID: |
44834757 |
Appl. No.: |
12/945801 |
Filed: |
November 12, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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PCT/US2009/044031 |
May 14, 2009 |
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12945801 |
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12258233 |
Oct 24, 2008 |
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PCT/US2009/044031 |
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12258233 |
Oct 24, 2008 |
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12258233 |
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61326567 |
Apr 21, 2010 |
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61127619 |
May 14, 2008 |
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61127619 |
May 14, 2008 |
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Current U.S.
Class: |
604/101.01 |
Current CPC
Class: |
A61M 25/104 20130101;
A61M 29/00 20130101; A61M 2025/0681 20130101; A61M 25/0662
20130101; A61M 25/005 20130101; A61M 2025/0024 20130101 |
Class at
Publication: |
604/101.01 |
International
Class: |
A61M 29/00 20060101
A61M029/00 |
Claims
1. An intra-aortic catheter, comprising: a first elongate member
comprising a proximal portion, a collapsible distal portion, and a
lumen extending through the proximal portion and the collapsible
distal portion; a second elongate member comprising a proximal end,
a distal end, and a chamber between the proximal end and the distal
end; and a dilator positioned within the lumen of the first
elongate member, the dilator configured to expand the collapsible
distal portion of the first elongate member from a first, collapsed
cross-sectional configuration to a second, expanded cross-sectional
configuration; wherein the chamber of the second elongate member is
configured to, when pressurized, collapse the collapsible distal
portion of the first elongate member from the second, expanded
cross-sectional configuration to a third, collapsed cross-sectional
configuration.
2. The catheter of claim 1, wherein at least a portion of the
collapsible distal portion of the first elongate member is
positioned adjacent to the second elongate member.
3. The catheter of claim 1, wherein at least a portion of the
collapsible distal portion of the first elongate member is
positioned within the chamber of the second elongate member.
4. The catheter of claim 3, wherein the distal end of the second
elongate member is bonded to the collapsible distal portion of the
first elongate member.
5. The catheter of claim 4, wherein the distal end of the second
elongate member is folded over a distal end of the first elongate
member and coupled to an inner surface of the first elongate
member.
6. The catheter of claim 4, wherein the distal end of the second
elongate member is folded over a distal end of the first elongate
member and coupled between an inner surface and outer surface of
the first elongate member.
7. The catheter of claim 4, wherein the proximal end of the second
elongate member is bonded to the proximal portion of the first
elongate member.
8. The catheter of claim 1, wherein the collapsible distal portion
comprises one or more longitudinal folds when in the first,
collapsed cross-sectional configuration.
9. The catheter of claim 8, wherein the one or more longitudinal
folds comprise two outside edges and two inside edges which form
longitudinal creases.
10. The catheter of claim 1, wherein the first elongate member
further comprises a malleable reinforcement embedded in at least a
portion of the collapsible distal portion.
11. The catheter of claim 10, wherein the malleable reinforcement
is configured to: reform in response to expansion of the dilator;
reform in response to pressurization of the chamber of the second
elongate member; and maintain the collapsible distal portion in
each of the first, collapsed cross-sectional configuration, the
second, enlarged cross-sectional configuration, and the third,
collapsed cross-sectional configuration.
12. The catheter of claim 11, wherein the malleable reinforcement
is a metal coil.
13. The catheter of claim 1, wherein the first, collapsed
cross-sectional configuration and the third, collapsed
cross-sectional configuration have a substantially similar
diameter.
14. The catheter of claim 1, wherein the dilator comprises a
balloon dilator.
15. The catheter of claim 1, wherein the first elongate member
further comprises a sheath hub at a proximal end of the first
elongate member, the sheath hub comprising a port operably
connected to the chamber of the second elongate member.
16. The catheter of claim 15, wherein the dilator comprises a
dilator hub at a proximal end of the dilator, the dilator hub
releasably coupled to the sheath hub.
17. The catheter of claim 1, wherein the dilator comprises a distal
fairing configured to cover a distal edge of the first elongate
member.
18. An intra-aortic catheter, comprising: a first elongate member
comprising a lumen; a second elongate member comprising one or more
vents and a distal balloon positioned distal to the one or more
vents; wherein the second elongate member is configured to be
positioned within the lumen of the first elongate member; wherein
the distal balloon is configured, when expanded, to form a seal
with an inside surface of the first elongate member such that a gap
is created in the lumen of the first elongate member between an
inner surface of the first elongate member and an outer surface of
the second elongate member, the gap positioned proximal to the
distal balloon; and wherein the one or more vents are configured to
evacuate the gap.
19. The catheter of claim 18, wherein the second elongate member
further comprises a hub, the hub comprising a first port and a
second port, wherein the first port is operably connected to the
one or more vents, and the second port is operably connected to the
distal balloon.
20. The catheter of claim 18, wherein the second elongate member
further comprises a proximal balloon positioned proximal to the one
or more vents, wherein the proximal balloon is configured, when
expanded, to form a seal with an inside surface of the first
elongate member proximal to the gap.
Description
PRIORITY CLAIM
[0001] This application claims the benefit of priority under U.S.C.
.sctn.119 of U.S. Provisional Patent Application Ser. No.
61/326,567, entitled "Expandable Iliac Sheath and Method of Use,"
filed on Apr. 21, 2010, and this application is a
continuation-in-part of International Patent Application No.
PCT/US2009/044031, entitled "Expandable Iliac Sheath and Method of
Use," filed on May 14, 2009, which is a continuation-in-part of
U.S. patent application Ser. No. 12/258,233, entitled "Expandable
Iliac Sheath and Method of Use," filed on Oct. 24, 2008, which
claims the benefit of priority of U.S. Provisional Patent
Application No. 61/127,619, filed May 14, 2008, entitled
"Expandable Iliac Sheath and Method of Use" and this application is
a continuation-in-part of U.S. patent application Ser. No.
12/258,233, entitled "Expandable Iliac Sheath and Method of Use,"
filed on Oct. 24, 2008, which claims the benefit of priority of
U.S. Provisional Patent Application No. 61/127,619, filed May 14,
2008, entitled "Expandable Iliac Sheath and Method of Use." The
contents of each of these applications are hereby incorporated by
reference in their entireties.
BACKGROUND OF THE DISCLOSURE
[0002] 1. Field of the Invention
[0003] The present inventions relate to medical devices for
percutaneously accessing body lumens and, more particularly, to
methods and devices for accessing the cardiovascular system.
[0004] 2. Description of the Related Art
[0005] A wide variety of diagnostic or therapeutic procedures
involve the introduction of a device into the vasculature through a
percutaneous or open surgical incision at an access site. Such
regions of the vasculature, preferred for access, include both the
iliac, subclavian, and femoral arteries. A percutaneous technique
commonly known for such vascular access is the Seldinger technique.
The Seldinger technique involves using a hollow needle to puncture
the skin and gain access to the selected artery or vein. A
guidewire is next placed through the hollow needle into the
selected region of vasculature. The guidewire may be advanced to a
target location in the vasculature, which can be more than 100 cm
away from the access site. The needle is removed and a tapered
dilator with a sheath and a central lumen in the dilator is
advanced over the guidewire into the vasculature. The dilator is
next removed and a guide catheter is advanced through the sheath
over the guidewire. The guide catheter can be advanced all the way,
or part way, to the target site. The guide catheter, following, or
without, removal of the guidewire can be used for directing
therapeutic or diagnostic catheters to regions of the vasculature
and central circulation, including external and internal structures
of the heart. A general objective of access systems, which have
been developed for this purpose, is to minimize the cross-sectional
area of the access lumen, while maximizing the available space for
the diagnostic or therapeutic catheter placement therethrough.
These procedures are especially suited for coronary angioplasty,
stent placement, cardiac valve replacement, stent-graft placement,
cerebrovascular embolic coil placement, diagnostic cardiac
catheterization, cardiac assist, and the like.
[0006] One type of cardiac procedure involves placement of a
collapsible cardiac valve in either the aortic, tricuspid, or
mitral position. Today, an aortic valve replacement procedure
involves the steps of inserting a hollow needle, with a hemostasis
valve affixed to the proximal end, into the femoral or iliac artery
of a patient via a percutaneous puncture. A guidewire is next
inserted through the hemostasis valve and the central lumen of the
needle into the femoral or iliac artery. The guidewire is routed,
under fluoroscopic control, cranially toward the heart, through the
aortic arch, through the aortic valve and into the left ventricle.
The hollow needle is removed from the patient leaving the guidewire
in place. An introduction sheath, including a tapered tip central
obturator or dilator having a hemostasis valve at the proximal end
and further including a central guidewire lumen is routed over the
guidewire, through the skin puncture, through the wall of the
artery, and into the central lumen of the iliac artery or aorta.
The central obturator or dilator is removed. A valve delivery
catheter is next advanced over the guidewire and through the
introduction sheath to the region of the aortic root. The aortic
valve is deployed in the region of the aortic root such that the
remnants of the original valve are outwardly dilated by the
implant, which includes a valve and expandable support stent. The
valve is seated firmly so as to become secured to the aortic valve
remnant. The delivery catheter is next removed from the patient
leaving the new valve in place. The sheath is next removed and
hemostasis is established using standard techniques for a vessel
puncture wound. Indications for percutaneous valve replacement
include a stenotic or incompetent aortic valve and a
contraindication to open surgical valve replacement.
[0007] Issues can arise, however, when the delivery catheter or
sheath are removed from the patient. Withdrawal of large catheters
and sheaths has been reported to cause disruption of vessel plaque
during removal or pullback through the aorta, iliac and femoral
arteries. This is especially problematic in very sick patients with
significant vascular disease that involves plaque, mural thrombus,
aneurysms, and other pathologies. The disruption of a region of
plaque or thrombus can cause emboli to break free from the vessel
wall, float downstream, and lodge within the lumen of smaller
distal vessels, blocking blood flow, and resulting in ischemia and
possibly tissue necrosis. Not only during withdrawal, but also
during insertion, do issues arise with insertion of sheaths and
catheters. In patients suffering from substantial cardiovascular
disease, atheroma, thrombus, and other plaque can build up on the
interior of the abdominal aorta, iliac arteries, and femoral
arteries. These vessels can have their lumen diameters
substantially reduced by these buildups and furthermore, the
vessels can become highly tortuous. Thus, insertion of catheters,
especially large diameter catheters and introducer sheaths can be
difficult or impossible because of vessel stenosis or wall
interference.
[0008] Suggested further reading related to the use of iliac or
femoral introducers for large catheters includes Gawenda M, and
Brunkwall J, Device-Related Problems of Thoracic Stent-Grafts, 1:
Zentralbl Chir. 2007 June; 132(3):205-10, the entirety of which is
hereby incorporated by reference herein.
[0009] It is desirable to protect the arteries, including the
femoral and iliac arteries, from a delivery catheter and sheath
during removal. A need remains, therefore, for improved access
technology, which allows a large diameter catheter or sheath to be
percutaneously or surgically introduced through the iliac, femoral,
or subclavian arteries, and then be removed without causing further
injury or complications to the patient.
SUMMARY OF THE INVENTIONS
[0010] One arrangement includes an introducer sheath having a
first, smaller cross-sectional area and a second, larger
cross-sectional area. In other arrangements, the introducer sheath
can have a third, smaller cross-sectional area that may
substantially be the same as the first, smaller cross-sectional
area or intermediate the first, smaller cross-sectional area and
the second, larger cross-sectional area. The introducer sheath can
include a hub and a length of sheath tubing. The sheath tubing and
the hub can form an axially elongate structure having a proximal
end, a distal end, a wall, and a lumen extending from approximately
the proximal end to the distal end. In certain embodiments, the
sheath tubing can have a proximal section, a central section, and a
distal section. The proximal section can be partially expandable,
fully expandable, or completely non-expandable, diametrically. In
some embodiments, the distal section can be expandable. The
introducer sheath can be suitable for iliac access, femoral access,
trans-femoral access, subclavian artery access, or aortic
access.
[0011] The sheath can be used as an introducer for long guiding
sheaths, other expandable sheaths, or catheter systems. The
expandable sheath can have the clinical benefit of being able to
radially dilate tissue, thus causing minimal tearing and tissue
trauma. The expandable sheath can be used to assist with
percutaneous vascular access procedures in that it can allow for a
small diameter access to the femoral, iliac, or subclavian arteries
that can then be expanded into a size large enough for introduction
of large interventional, therapeutic, or diagnostic devices
therethrough. Interventional cardiologists generally prefer to
perform interventional procedures where the access is percutaneous
and does not require a surgical cutdown. Should a surgical cutdown
be required for access, a surgeon is generally brought in to
perform the access. The expandable arterial access sheath can
eliminate the need for a cutdown and the surgical support, reducing
time, procedure cost, trauma to the patient, and improving patient
outcomes.
[0012] In certain embodiments, the central section can be
expandable. In some embodiments, the central section can include a
polymeric wall with reinforcing elements that can maintain the
cross-sectional shape of the central section prior to expansion,
and after expansion. In some embodiments, the central section can
include a polymeric wall that can be non-distensible but otherwise
foldable and free from any reinforcing elements. In these
non-reinforced embodiments, the central section can possess the
properties of flexibility but can have minimal structure and thus,
cannot maintain a cross-sectional shape. In some embodiments, the
central section can include longitudinally disposed reinforcing
elements that provide column strength and tensile strength but
offer little or no cross-sectional shape retention.
[0013] In some embodiments, the distal section can include a
polymeric wall with reinforcing elements that provide a degree of
retention of cross-sectional shape. The distal section can include
weak reinforcing elements that provide some control over the shape
of the polymeric wall but can be easily deformed into a collapsed
configuration upon exposure to external forces such as those
imposed by a blood vessel wall. The distal section can include
polymeric materials that can be plastically deformed and do not
substantially spring back following dilation. In some embodiments,
the distal end can be subject to remodeling by inflation of the
expansion balloon under pressures ranging between 10 and 40
atmospheres.
[0014] In some embodiments, the distal end of the sheath can
include a flared component that becomes larger in diameter as the
sheath extends axially in the distal direction. The flared
component can include a taper, or it can include a taper and a
region of relatively constant diameter coupled to or integral to
the tapered region at the most distal end. The flared component can
be integral to the distal end of the expandable portion of the
sheath, or it can be coupled thereto. The flared component can be
expanded using a balloon dilator, it can be expanded using
self-expansion modalities, or it can include self-expansion with
balloon dilator assist. The self-expansion can be due to resilient
spring forces, or due to shape memory forces generated by sheath
reinforcement components fabricated from nitinol, or other shape
memory materials. The flared configuration can facilitate
re-capture or removal of instruments or implantable devices such as
percutaneously delivered aortic heart valves. In an exemplary
embodiment, the flared configuration can also facilitate removal of
the natural aortic valve root, should excision of the aortic valve
root be required. The expandable, flared region of the sheath can
range in length between 1-cm and 10-cm, with a preferred range of
2-cm to 5-cm. In some embodiments, the flared region can use the
same balloon as the rest of the distal expandable region for
expansion. In some embodiments, the flared region can be expanded
by a separate balloon.
[0015] In some embodiments, the proximal end of the sheath can
include a hub incorporating one or more hemostasis-type valves. The
hub can include a single catheter insertion port or can include a
plurality of catheter insertion ports. Each catheter insertion port
preferably includes hemostasis valves, stopcocks, or the like to
prevent blood leakage from the catheter. The hub can further
include one or more purge ports, which can operably couple to the
internal lumen of the hub and can be terminated by stopcocks or
other valves.
[0016] In some embodiments, the diametrically or radially
expandable elements of the catheter can be configured as a tube
having a plurality of longitudinal folds. The expandable regions or
elements, located in the proximal section, distal section, or the
center section of the sheath or catheter, can be creased into these
folds and bent to form a first, smaller, folded cross-sectional
area. The expandable regions or elements can be folded over a
central dilator catheter including, for example, an
angioplasty-type balloon, a catheter shaft, a balloon inflation
port at the proximal end, a guidewire lumen, and the like. Upon
selective inflation of the angioplasty-type, non-elastomeric,
non-distensible, balloon by application of fluid pressure into an
appropriate port on the proximal end of the dilator catheter, the
expandable regions can unfold into a second, larger,
cross-sectional shape. The central dilator catheter can be deflated
and removed from the sheath to create a large cross-section center
lumen suitable for the introduction of catheters, delivery
catheters, implantable devices, or the like.
[0017] In some embodiments, the expandable introducer sheath
includes a proximal, expandable section. The proximal expandable
section includes a composite tubular structure fabricated from an
inner polymeric layer of polyethylene, an outer polymeric layer of
polyethylene, and a reinforcement layer sandwiched between the two
polymer layers. The reinforcement layer can include a coil of flat,
fully annealed, stainless steel wire with a width of about 0.010
inches, with a range of 0.005 to 0.025 inches, and a thickness of
about 0.003 inches, with a range of 0.002 to 0.004 inches. The
proximal, expandable region can be coupled to the proximal end to a
non-expandable length of sheath tubing of the same or similar
inside diameter, or it can be coupled directly to the sheath hub.
The distal end of the proximal expandable region can be coupled to
a central expandable region that includes inelastic polymeric
materials. The central expandable region can include a membrane of
polymers bonded, welded, or surrounding a braid, or other fabric
reinforcing structure that provides a level of column strength and
a level of tensile strength for the central expandable region. The
distal end of the central expandable region can be coupled to a
distal expandable region configured similarly to the proximal
expandable region except that the distal expandable region can be
somewhat weaker so that the distal expandable region can be easily
collapsed following expansion.
[0018] In some embodiments, the sheath tubing can include a
proximal region wherein a reinforcing layer of spring stainless
steel ribbon can be wound into a coil with a width of about 0.005
to 0.025 inches and a thickness of about 0.002 to 0.004 inches. The
coil spacing can range between 0.001 inches and 0.050 inches.
[0019] In another embodiment, the sheath can include a proximal
non-expandable region and a distal expandable region. The distal
expandable region can include between 10% and 95% of the catheter
shaft length.
[0020] The distal, expandable region can include a reinforcing
layer of malleable stainless steel ribbon or flat wire wound into a
coil with similar dimensions as in the proximal region. The entire
length, or a substantial portion thereof, can include an additional
reinforcing layer, or layers, of braided material fabricated from
materials such as, but not limited to, PEN, polyester, stainless
steel, titanium, nitinol, cobalt nickel alloy, polyamide,
polyimide, or the like. In some embodiments, the reinforcing
structure, generally sandwiched between an outer and an inner layer
of polymeric wall, can include an inner layer of polymer overlaid
by a first reinforcing braid layer, overlaid by a coil
reinforcement, finally overlaid with an outside layer of polymeric
material. In another embodiment, the inner layer of polymeric
material can be overlaid by the coil reinforcement, which can be
overlaid by the braided reinforcement, which can be finally
overlaid with the outside layer of polymeric material. In some
embodiments, the inner layer of polymeric material can be overlaid
by the braided layer, which can be overlaid by the coil winding,
which can be overlaid by another layer of braid, which can be
finally overlaid by the outer polymeric layer.
[0021] In some embodiments, the sheath dilator can be configured
with a PET balloon coupled to a Hytrel shaft. The Hytrel shaft can
include an inner and an outer tube concentrically disposed with an
annulus between the two tubes. The distal end of the dilator
balloon can be coupled to the inner Hytrel tubing. The proximal end
of the dilator balloon can be larger in diameter and can be coupled
to the outer Hytrel tubing in this embodiment. The outer Hytrel
tubing can extend just inside the center volume of the dilator
balloon and the annulus between the outer tube and the inner tube
can be in fluid communication, operably connected to, the center
volume of the dilator balloon. The annulus can be operably in fluid
communication with an inflation port integral to, or coupled to,
the dilator hub. In some embodiment, an outer polymer tube, such as
the outer Hytrel tube of the preceding embodiment, can be omitted
and the dilator balloon can include a proximal tail that can extend
proximally to bond and seal within the dilator hub or sidearm. In
some embodiments, the pressurization annulus for the balloon can
reside between the dilator balloon and the inner polymer tube, the
pressurization annulus being operably connected to an inflation
port on the dilator hub. The interior of the inner dilator tube
includes a guidewire lumen suitable for advancing the entire system
over a guidewire suitable for aortic access. Such aortic access
guidewires typically can be 0.035 or 0.038 inches in diameter and
can be relatively stiff.
[0022] The sheath can be folded into one or more longitudinally
oriented folds and wrapped around the dilator, with collapsed
dilator balloon. The malleable elements in the proximal and distal
expandable regions can maintain the configuration of the system in
the collapsed state. An optional outer jacket, which can have
attached, peel-away, tear-away, or removable before use
configurations, can be used to encase part or all of the
diametrically collapsed sheath tubing. In some embodiments, the
sheath can further include a thin FEP, PFA, or PTFE tube over the
outside of the sheath. This fluoropolymer outer covering need not
be removed. The outer covering can function to protect a soft
polyethylene sheath material from hard vascular deposits such as
atheroma.
[0023] In some embodiments, the central region can include
elastomeric polymer structure with an optional braid reinforcement
that can permit the central region to simply expand diametrically
from a first smaller diameter to a second larger diameter without
the use of folds. An internal slip layer of PTFE, FEP, PFA, or
other highly lubricious material can be used to facilitate passage
of a catheter through the central region to prevent clinging. The
internal slip layer can be the inner layer of the polymer sandwich
within which the reinforcing coils or braids can be embedded.
[0024] Once the expandable introducer sheath has been advanced so
that the distal end reaches just above the aortic bifurcation, the
dilator is expanded at pressures of between 10 and 40 atmospheres,
and preferably between 15 and 30 atmospheres. The dilator can next
be deflated and removed from the central lumen of the sheath.
[0025] In some embodiments, the sheath can include a flexible shaft
configured with an elastomeric outer membrane and a reinforcing
layer configured as a braided structure that is capable of changing
the diameter. The sheath can be inserted into a patient in a first,
smaller cross-sectional configuration, preferably over a small
diameter dilator or tapered obturator. The obturator or tapered
dilator can next be removed and a hollow central dilator of large
diameter can be inserted into the interior lumen of the sheath.
Upon insertion of the large diameter, hollow central dilator into
the flexible shaft of the sheath, the sheath can expand
diametrically to a second, larger, cross-sectional area, diameter,
or radius. One or more catheters can be inserted therethrough to
reach a target site within the vasculature. Following completion of
the procedure, the central dilator can be removed resulting in
elastomeric contraction of the outer membrane to a first, smaller
cross-sectional area. The sheath can next be removed from the
patient in the first, smaller, cross-sectional area configuration.
The sheath can be configured using principles and design elements
as described in U.S. Pat. No. 7,309,334 by Gerard von Hoffmann,
titled "Intracranial Aspiration Catheter", the entirety of which is
hereby incorporated herein by reference.
[0026] The reinforcement of the expandable regions can include
wire, preferably malleable wire. The wire can have a round
cross-section, a rectangular cross-section, a ribbon-like
cross-section, or the like. The malleable wire can be bent by a
dilator balloon, tapered dilator, hollow dilator, or the like, into
the second, larger cross-section and the strength of the malleable
wire can substantially overcome any resilient spring-back imparted
by the polymeric component of the sheath wall.
[0027] In some embodiments, the wire can have elastomeric
properties or shape memory properties. These embodiments can
utilize shape-memory wire, pseudoelastic wire, superelastic wire,
elastomeric wire, or the like. The wire can be nitinol, stainless
steel, cobalt nickel alloy, or the like. The wire, in the
shape-memory configuration can have an austenite finish temperature
of around 25 to 35 degrees centigrade, preferably between 28 and 32
degrees centigrade so that body temperature blood can cause the
wire mesh to be biased to the larger, expanded configuration.
[0028] In some embodiments, the expandable region can include
polymeric encapsulation of a braided or otherwise expandable shape
memory reinforcing structure. The reinforcing elements or structure
can have shape-memory characteristics. The sheath is inserted into
the patient in the first, small cross-sectional area. The
reinforcing elements can be maintained below the martensite start
temperature so that the reinforcing elements can be substantially
malleable, even at body temperature (approximately 37.degree. C.).
The sheath wall can next be dilated with the balloon dilator as
described herein. The dilator can next be removed and the sheath
can become host to therapeutic or diagnostic catheters, which can
be inserted therethrough. Following removal of the catheters,
electricity can be applied to lead wires at proximal end of the
sheath. The electrical leads can be operably connected to heaters
in the vicinity of the reinforcing elements, or the electrical
leads can be operably connected to each end of the reinforcing
elements. The electricity causes Ohmic or resistive heating of the
reinforcing elements to above their austenite finish temperature.
The reinforcing structure, having been shape-set in the small
diameter configuration, can return to that small diameter
configuration, bringing the entire expandable sheath wall down with
it, to facilitate removal of the sheath from the patient. An
austenite finish temperature of around 42.degree. C. can be used in
this application.
[0029] The dilator catheter can include an inner and outer member.
The materials of the inner member and the outer member can include
Hytrel, PEEK, composite, reinforced construction, polyester,
polyurethane, polyethylene, or the like. The catheter hub can be
fabricated from materials such as, but not limited to,
polycarbonate, acrylonitrile butadiene styrene (ABS), polyurethane,
polyvinyl chloride, and the like. The dilator balloon can be
fabricated from stretch blow-molded polyester polyamide, polyamide,
or polyester blends, using materials such as, for example, Eastman
PET 9921 or similar.
[0030] In some embodiments, a coating is applied to the expandable
areas to generate an inwardly biased, radially oriented contraction
force. The expandable area can be forced to expand radially against
the bias force of the coating. Once the radial expansion force is
removed, the expandable area can remain biased radially inward
toward the smallest diameter, to which it can travel unless
prevented from doing so.
[0031] The system can include radiopacity enhancements to improve
visualization under fluoroscopy. Radiopaque markers can be coupled
to the distal end of the sheath to denote the distal end, the
extents of the expandable region or regions, or even the
orientation of the sheath. The radiopaque markers can include bands
or windings of metal such as, but not limited to, tantalum,
platinum, platinum iridium, gold, and the like.
[0032] In some embodiments of the sheath wall construction, an
inner layer of polymer and an outer layer of polymer can sandwich a
reinforcing layer. The reinforcing layer can be a coil of metal
such as, but not limited to, titanium, stainless steel, cobalt
nickel alloy, nitinol, tantalum, or the like. The coil can
preferably be malleable, with little or no spring properties, and
not exhibit any elastomeric tendencies. The coil can be fabricated
from flat wire with a thickness of 0.001 to 0.010 inches and
preferably 0.002 to 0.005 inches. The width of the flat wire can
range from 0.005 to 0.050 inches and preferably from 0.008 to 0.025
inches. The spacing between the coils can, for example, range from
substantially 0 to approximately 5 times the width of the coil
wire. The coils can be fabricated from round stock, flat stock, or
the like. The reinforcement can be sandwiched between the inner
layer and the outer layer of polymeric material, wherein the inner
and outer layers can be bonded or welded to each other through the
space between the coils. The inner and outer polymeric layers can
be fabricated from the same or different materials. Suitable
materials for the inner and outer layers include, but are not
limited to, polyurethane, silicone, Hytrel, PEEK, polyethylene,
HDPE, LDPE, polyester, polyethylene blends, or the like. In some
embodiments, a plastically deformable, malleable, or annealed,
braid structure can also be used for reinforcement to beneficially
eliminate the need for the malleable coil and permit a reduction in
wall thickness while retaining the tensile strength and
torqueability of the braid.
[0033] In some embodiments, the sheath shaft can include multiple
regions of varying flexibility along the axial length of the shaft.
In some embodiments, the catheter shaft can have at least two
regions of different flexibility. In some embodiments, the catheter
shaft can include three or more (with a practical upper limit of
six) regions of different flexibility. In some embodiments, the
sheath shaft flexibility can be reduced toward the proximal end of
the catheter and increased moving toward the distal end of the
catheter. Moving from the proximal to the distal end of the
catheter shaft, the flexibility of a given discreet section can be
greater than the flexibility of the region just proximal and
adjacent to said discreet section. A sheath having a substantially
collapsed, small diameter distal region can exhibit significantly
increased flexibility in that area over the flexibility in
non-expandable, or fully expanded, expandable regions. Such
flexibility can be especially useful when traversing tortuous or
curved anatomy such as the aortic arch. Following such traverse,
the sheath can be expanded to create a stiffer, larger diameter
structure. Such construction can be especially useful for the
delivery catheter for an aortic valve, which needs to approach the
aortic root from the anatomically distal (downstream) aspect.
[0034] Another embodiment includes a catheter configured to deliver
a valve to the heart. In an embodiment, the delivery catheter for
an aortic valve can be configured with an expanded inner diameter
ranging from about 12 French to about 40 French, with a preferred
range of about 16 French to 26 French. In an unexpanded
configuration, the distal, unexpanded outside diameter of the
delivery catheter for the aortic valve can range between about 6
French and 16 French. The length of the distal, expandable region
can, in some embodiments, equal at least the arc length of the
aortic arch and can range between about 15 cm and 40 cm. In some
embodiments, the sheath can have a working length of about 9 to 55
cm with preferred working lengths ranging from about 15 to 45 cm.
The general construction of the aortic valve delivery catheter can
be as described in U.S. Provisional Patent Application Ser. No.
60/674,226, filed Apr. 22, 2005, titled Expandable Trans-Septal
Sheath, the entirety of which is hereby incorporated herein by
reference. In some embodiments, an expandable delivery sheath can
be used to deliver a catheter, or a prosthesis, to the heart
through the subclavian artery. In some embodiments, the sheath
working length can be generally shorter than the working length of
an iliac access sheath. In some embodiments anticipated herein, the
valve prosthesis replacement can be delivered retrograde to the
aortic valve root.
[0035] In some embodiments, the iliac, or iliofemoral, sheath can
be configured to be inserted into the femoral or iliac arteries and
can be routed so that the distal end is within the aorta. In some
embodiments, the working length of the introducer sheath can be
such that the sheath reaches just proximal to the aortic
bifurcation. In some embodiments, the working length of the
introducer can be such that the sheath can reach well into the
descending abdominal aorta and can extend to a position
approximately between the aortic bifurcation and the renal
arteries, or just beyond. In some embodiments, the working length
of the introducer sheath can range between about 20 and 55 cm with
a preferred length of 25 to 45 cm. The expandable distal region can
include nearly, or substantially, all of the sheath tubing, leaving
only a small non-deformable or non-expandable region at the
proximal end to facilitate attachment to the sheath hub.
[0036] In some embodiments a method of use can include an
expandable iliac sheath which can be provided in an aseptic, or
sterile, package and can be sterilized by ethylene oxide, gamma
irradiation, electron beam irradiation, or the like. The patient
can be prepared in the standard hospital fashion for surgery and
can be appropriately draped. A percutaneous needlestick can be made
into the iliac arteries using the Seldinger technique described
earlier in this document. A guidewire can be advanced through the
hollow 18-gauge needle and the needle can be removed. The
percutaneous access site can optionally be dilated with an Amplatz
dilator or similar device at this time. The introducer sheath, in
the first, small cross-sectional configuration with the dilator,
can be advanced over the guidewire and into the iliac artery where
it can be advanced into the abdominal aorta. The introducer sheath
can next be dilated to the second, larger cross-sectional
configuration, using the pre-inserted dilator or by other suitable
means. The dilator can next be removed and any hemostasis valves
can be checked for closure at the proximal end of the sheath.
Interventional catheters can next be advanced through the
expandable introducer sheath and toward their anatomical target.
Following completion of the procedure, the interventional catheters
can be removed from the expandable iliac introducer sheath, again
checking to ensure that there is no hemorrhage from the valves or
ports at the proximal end of the sheath. The sheath can be removed
from the patient in one of three ways. In some embodiments, the
sheath can be simply withdrawn from the patient without collapsing
the sheath. In some embodiments, the sheath can be withdrawn from
the patient without actively collapsing the sheath but the sheath
collapses slightly following removal of the interventional
catheters to ease withdrawal. In some embodiments, the sheath can
be actively reduced in diameter or cross-section and can then be
withdrawn from the patient. Hemostasis can be maintained using
standard hospital technique or by the application of a commercial
percutaneous access hemorrhage control device.
[0037] Some embodiments of the sheath can cause sheath re-collapse,
in the radial, diametric, or cross-sectional directions. In some
embodiments, shape-memory nitinol can be heated to above body
temperature to cause restoration to austenite finish temperature
and return to a pre-set, collapsed shape. In some embodiments, the
outer layer of the sheath can be separate from inner layers. The
outer layer of the sheath can include substantially non-compliant
material or it can include substantially semi-compliant materials,
or a combination thereof. An inflation port at the proximal sheath
hub can be operably connected to the potential space between the
outer layer of the sheath and the inner layers. Pressurization of
the potential space between the outer layer and the inner layers
can preferentially coerce, crush, force, deform, collapse, re-fold,
or otherwise move the inner layers inward to a greater degree.
Following removal of the pressurization within the potential space,
the collapsed sheath and the now flaccid outer layer can be removed
from the patient with less potential to scrape or cause damage to
the walls of the artery or blood vessel. In some embodiments, the
outer layer can include two layers sealed to each other such that
pressurization occurs between the double wall outer layer. These
embodiments can be useful when it is difficult to seal the outer
layer to the inner layers due to material incompatibilities. In
other embodiments, the sheath can include an outer pressure jacket
and a side-balloon disposed alongside the sheath tubing running
substantially parallel to the longitudinal axis of the sheath
tubing. Pressurization of the side-balloon can cause the sheath
wall to collapse or re-fold due to the force generated between the
outer pressure jacket and the deformable sheath tubing by the
side-balloon. In some embodiments, the side-balloon can be folded
in half lengthwise and stacked so that both balloon chambers
provide force against the sheath tube when inflated. The folded
side-balloon advantageously can function without the need for a
distal seal, which can be difficult to create in the types of
materials necessary for these balloons.
[0038] The main reasons for the malleable embodiments include
control over cross-sectional shape, ability to embed the
reinforcement in the polymer layers without needing to create some
difficult-to-manufacture decoupling of the polymer and the
reinforcement, the high strength of the sheath following placement,
and prevention of lumen re-collapse caused by body tissue. The
ability of this device to remodel to the desired shape to generate
a superhighway for placement of implants and other medical devices
is superior to anything available today. Furthermore, the device
can provide a relatively smooth interior lumen, which can allow
passage of instruments and implants of very large size without
excessive binding or friction. No other sheath exists today that
has these benefits. The malleable reinforcements embedded within
the sheath can be configured to generate sufficient force that they
can control and maintain the diameter of the radially collapsed,
unexpanded sheath. The malleable reinforcements can be further
configured to maintain the sheath in the open, radially expanded
configuration, following dilation with a balloon or other dilator,
residing within the sheath lumen. The structure of the malleable
metal reinforcement can be sufficient to overcome, or dominate, any
resilient or structural forces exerted by the polymeric components
of the sheath tubing, which generally can surround, or encase, the
reinforcement. The structure of the malleable metal reinforcement
also can be sufficient to overcome any inwardly biased forces
imposed by any tissue through which the sheath can be inserted,
such as, for example, muscle mass and fascia lying between the skin
and the femoral or iliac arteries.
[0039] In some embodiments, the sheath assembly can include a
malleable reinforcement embedded within a polymeric sheath material
which can form an axially elongate tube having a proximal end, a
distal end, and a lumen extending therethrough. The sheath can
further include a substantially non-distensible outer pressure
jacket that surrounds the exterior of the polymeric sheath material
but which can not be attached thereto. A secondary balloon can be
provided, in the collapsed configuration, between the pressure
jacket and the exterior of the polymeric sheath wall. Following
expansion of the sheath by means of an internal dilator located
within the primary lumen of the sheath and deflation of the
dilator, the sheath can be used to introduce other medical
instruments, catheters, and the like. At the conclusion of the
procedure, or other desired point in the procedure, the secondary
balloon can be inflated to compress the radially expanded sheath
inward. The secondary balloon can be held against the sheath wall
by the pressure jacket. Inflation of the secondary balloon can
punch in one side of the sheath and can generate tension on the
pressure jacket that causes the sheath to fold into a "U" shape.
Deflation of the secondary balloon can now result in a sheath with
a much-reduced cross-sectional profile that is easily removable
from the patient. In some embodiments, the secondary balloon can be
provided with a closed distal end, like a soda bottle, to minimize
the chance of leakage. In some embodiments, the secondary balloon
can be sealed to itself at the distal end using welding techniques,
adhesives, crimping, fasteners, or the like. The proximal end of
the secondary balloon can be coupled and operably connected to an
inflation port or lumen. In some embodiments, the secondary balloon
can be folded back on itself at the distal end such that the
secondary balloon forms a double balloon that can be stacked
radially to maximize the refolding tendency and to eliminate a
distal balloon weld or seal that could potentially leak. In some
embodiments, the secondary balloon can be positioned along and
inside the longitudinal fold of the compressed primary sheath tube.
The presence of the folded secondary balloon, or even slight
inflation thereof can reduce any bleeding that occurs through the
channel created by the fold between the interior of the patient
blood vessel and the exterior region of the vessel or of the
patient.
[0040] In some embodiments, where the sheath refolding can be
generated by pressure buildup between the pressure jacket and the
sheath itself, the distal bond can be reinforced by folding the
pressure jacket over the distal end of the sheath, everting the
pressure jacket distal end inside the sheath, and subsequent heat
sealing or welding of the distal end of the pressure jacket to the
sheath distal end. Such an everted pressure jacket distal end may
benefit from a necking operation to reduce the diameter prior to
eversion and welding. A high-pressure balloon such as one
fabricated from PET, Nylon, or the like, can be used to iron out
wrinkles on the interior of the distal end of the sheath prior to
welding. The everted pressure jacket can, in some embodiments, be
welded to the exterior of the main sheath tube, rather than the
interior.
[0041] In some embodiments, a shim, such as a short tube fabricated
from PET or other suitable polymer, can be inserted into the
interior of the sheath to increase the strength and minimize the
risk of blowout through the sheath polymer wall, which can be
fabricated from Hytrel for example and which can generally be
weaker than the PET pressure jacket but can be bonded thereto. The
shim can have a length ranging between about 0.020 and 0.500 inches
with a preferred range of about 0.050 inches to about 0.250 inches.
Such reinforcements of the polymeric wall and pressure jacket at
the distal end of the sheath can help prevent peeling apart of the
welded layers and use the pressure to force the layers together,
rather than apart.
[0042] In some embodiments, the inner layer of sheath material,
which can be Hytrel 55D for example, can be brought forward past
the distal end of the sheath, folded outward, and welded to the PET
pressure jacket. The welding can be performed using radiofrequency
heating, hot air heating (hot box), laser welding, a resistive
heater, ultrasonic welding, or the like. Heating temperatures can
range between about 300.degree. F. and 600.degree. F., depending on
the tubing thicknesses, configurations, chemical makeup, and the
like with temperatures of about 400.degree. F. being suitable for
welding PET to Hytrel. Expanding collets, tapered mandrels,
exterior heat shrink tubing and other manufacturing aids can be
used to compress the tubing and facilitate welding with the
application of heat. Mandrels can be fabricated from PTFE or other
fluoropolymers to provide for easy removal following the bonding
process.
[0043] The proximal end of the pressure jacket can be routed into
an annulus or lumen that can be operably connected to a collapse or
refolding pressure port on the sheath hub. The collapse pressure
port can be terminated with a female Luer lock or other suitable
medical connector and can further include a valve such as a
stopcock or one-way check valve to prevent fluid loss except when a
male Luer can be inserted therein.
[0044] In some embodiments, an internal pressure jacket can be
provided that can be coupled to the interior of the sheath
polymeric tubing such that pressurization of the space between the
internal pressure jacket and the sheath tubing causes the internal
pressure jacket to collapse radially inward and the sheath tubing
to expand radially outward. Following radial expansion of the
sheath tubing, the space between the internal pressure jacket and
the sheath tubing can be evacuated of fluid to pull the internal
pressure jacket against the inside diameter of the sheath lumen and
maximize the lumen for instrument and catheter passage. In this
embodiment, the sheath can be radially expanded without the need
for a separate, removable dilator. The same exterior pressure
jacket or parallel secondary balloon can be used to re-collapse
this design prior to removal from the patient.
[0045] For purposes of summarizing the invention, certain aspects,
advantages and novel features of the invention are described
herein. It is to be understood that not necessarily all such
advantages may be achieved in accordance with any particular
embodiment of the invention. Thus, for example, those skilled in
the art will recognize that the invention may be embodied or
carried out in a manner that achieves one advantage or group of
advantages as taught herein without necessarily achieving other
advantages as may be taught or suggested herein. These and other
objects and advantages of the present invention will be more
apparent from the following description taken in conjunction with
the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0046] A general architecture that implements the various features
of the invention will now be described with reference to the
drawings. The drawings and the associated descriptions are provided
to illustrate embodiments of the invention and not to limit the
scope of the invention. Throughout the drawings, reference numbers
are re-used to indicate correspondence between referenced
elements.
[0047] FIG. 1 is a front view schematic representation of the human
circulatory system including the heart, the aorta, the iliac and
femoral arteries, according to an embodiment of the invention;
[0048] FIG. 2 is a front view schematic representation of the human
circulatory system with a guidewire routed from the iliac artery
into the aorta, according to an embodiment of the invention;
[0049] FIG. 3A illustrates an expandable introducer sheath having
three regions of expandability, in a radially collapsed
configuration with a dilator catheter in place, according to an
embodiment of the invention;
[0050] FIG. 3B illustrates the expandable introducer sheath of FIG.
1A in a radially expanded configuration and with the dilator
catheter removed, according to an embodiment of the invention;
[0051] FIG. 4A illustrates a one-way expandable introducer sheath
having a single area of expandability, in a first, unexpanded
configuration with a dilator inserted therein, according to an
embodiment of the invention;
[0052] FIG. 4B illustrates the one-way expandable introducer sheath
of FIG. 4A in an expanded configuration with the dilator having
been removed, according to an embodiment of the invention;
[0053] FIG. 4C illustrates a dilator capable of expanding the
sheath, with the dilator balloon in an expanded configuration,
according to an embodiment of the invention;
[0054] FIG. 5A illustrates a two-way expandable introducer sheath
having a single area of expandability, in a first, unexpanded
configuration, according to an embodiment of the invention;
[0055] FIG. 5B illustrates the two-way expandable introducer sheath
of FIG. 5A in a second, expanded configuration, according to an
embodiment of the invention;
[0056] FIG. 5C illustrates the two-way expandable introducer sheath
of FIG. 5A following return to a third, actively collapsed
configuration, according to an embodiment of the invention;
[0057] FIG. 6A illustrates an expandable introducer sheath and
dilator, in a first, radially collapsed configuration, according to
an embodiment of the invention;
[0058] FIG. 6B illustrates the expandable introducer sheath of FIG.
6A having been radially expanded and the dilator removed, according
to an embodiment of the invention;
[0059] FIG. 6C illustrates the fully expanded introducer sheath of
FIG. 6A with a prosthetic cardiac valve delivery catheter having
advanced a prosthetic cardiac valve through the sheath, according
to an embodiment of the invention;
[0060] FIG. 7 illustrates an expandable introducer sheath advanced
into the iliac artery of a patient in a first, radially collapsed
configuration, according to an embodiment of the invention;
[0061] FIG. 8 illustrates an expandable introducer sheath having
been dilated within the iliac artery of a patient, according to an
embodiment of the invention;
[0062] FIG. 9 illustrates a prosthetic aortic valve delivery
catheter advanced through the expanded introducer sheath of FIG.
6B, according to an embodiment of the invention;
[0063] FIG. 10 illustrates a diametrically collapsed aortic sheath
inserted into an iliac artery and then routed around the aortic
arch and positioned within the aortic root, according to an
embodiment of the invention;
[0064] FIG. 11 illustrates the aortic sheath of FIG. 10 which has
had an expandable distal region expanded by the dilator, following
which the dilator has been removed, according to an embodiment of
the invention;
[0065] FIG. 12 illustrates a prosthetic aortic heart valve
replacement being placed through the sheath of FIG. 10 by means of
a catheter introducer, according to an embodiment of the
invention;
[0066] FIG. 13 illustrates a prosthetic aortic heart valve
replacement being placed through a subclavian artery access sheath,
according to an embodiment of the invention;
[0067] FIG. 14A illustrates a lateral cross-section of a distal
region of an expandable arterial sheath including a single fold,
according to an embodiment of the invention;
[0068] FIG. 14B illustrates a lateral cross-section of a distal
region of an expandable arterial sheath including a double fold,
according to an embodiment of the invention;
[0069] FIG. 15 illustrates a short, expandable iliofemoral
introducer sheath advanced into the aorta just proximal to the
aortic bifurcation in a patient in a first, radially collapsed
configuration, according to an embodiment of the invention;
[0070] FIG. 16a illustrates a short, expandable, re-collapsible
iliofemoral introducer sheath and dilator in a first, radially
collapsed configuration, according to an embodiment of the
invention;
[0071] FIG. 16b illustrates the expandable, re-collapsible
iliofemoral introducer of FIG. 16a in a second, radially expanded
configuration with the inflated dilator still in place, according
to an embodiment of the invention;
[0072] FIG. 16c illustrates the iliofemoral introducer of FIG. 16b
with the dilator removed and the space between an outer jacket and
the introducer sheath pressurized to collapse the introducer sheath
distal tube to a third, radially collapsed configuration, according
to an embodiment of the invention;
[0073] FIG. 17a illustrates a collapsing obturator for use with
expandable introducer sheaths, according to an embodiment of the
invention;
[0074] FIG. 17b illustrates the collapsing obturator of FIG. 17A
having been inserted into a diametrically expanded introducer
sheath, and then pressurized to expand two sealing balloons,
according to an embodiment of the invention;
[0075] FIG. 17c illustrates the collapsing obturator of FIG. 17A
within the introducer sheath with the two sealing balloons inflated
and the region between the sealing balloons but outside the
collapsing obturator depressurized to radially collapse the
expandable introducer sheath tubing, according to an embodiment of
the invention;
[0076] FIG. 18a illustrates an expanded view of the expandable,
re-collapsible introducer of FIGS. 16a-16c showing the inflation
and deflation lumen within the hub and outer jacket, according to
an embodiment of the invention;
[0077] FIG. 18b illustrates a side view of a forming obturator
configured to control the shape of the distal collapsible region of
an introducer sheath, according to an embodiment of the
invention;
[0078] FIG. 18c illustrates a cross-sectional view of a forming or
collapsing obturator having a three-pronged profile, according to
an embodiment of the invention;
[0079] FIG. 18d illustrates a cross-sectional view of a forming or
collapsing obturator having a splayed U configuration, according to
an embodiment of the invention;
[0080] FIG. 19 illustrates an expandable, re-collapsible introducer
that includes a non-removable self-expansion element in a radially
expanded state, according to an embodiment of the invention
[0081] FIG. 20 illustrates a side view, with breakaway in regions
distal to the sheath hub, of a re-collapsible introducer that
includes an outer pressure jacket welded to the sheath wall at the
distal end, according to an embodiment of the invention;
[0082] FIG. 21 illustrates a cross-sectional side view of a distal
end of a re-collapsible introducer or sheath that includes an outer
pressure jacket folded over the distal end of the sheath and welded
to the interior of the sheath wall, according to an embodiment of
the invention;
[0083] FIG. 22 illustrates a cross-sectional side view of a distal
end of a re-collapsible introducer that includes an outer pressure
jacket folded over the distal end of the sheath and welded between
the inner and outer layers of the sheath wall, according to an
embodiment of the invention;
[0084] FIG. 23 illustrates a cross-sectional side view of a distal
end of a re-collapsible introducer that includes an outer pressure
jacket folded over the distal end of the sheath and welded to the
exterior of the sheath wall, according to an embodiment of the
invention;
[0085] FIG. 24 illustrates a cross-sectional side view of the
distal end of the re-collapsible introducer of FIG. 20, detailing
how the outer pressure jacket is welded to the exterior of the
sheath wall, according to an embodiment of the invention;
[0086] FIG. 25A illustrates a cross-sectional side view of a
re-collapsible introducer that includes a side balloon sandwiched
between the sheath wall and an outer pressure jacket with the
sheath fully expanded, according to an embodiment of the
invention;
[0087] FIG. 25B illustrates a cross-sectional side view of the
re-collapsible introducer of FIG. 25A wherein the side balloon has
been expanded under pressure, forcing the sheath wall to collapse
away from the outer pressure jacket, according to an embodiment of
the invention;
[0088] FIG. 25C illustrates a cross-sectional side view of the
re-collapsible introducer of FIG. 25B wherein the side balloon has
been evacuated thus drawing down the exterior of the side balloon
and the pressure jacket to form a low-profile sheath, according to
an embodiment of the invention;
[0089] FIG. 26A illustrates a cross-sectional side view of a
re-collapsible introducer wherein the side balloon is formed
continuously, without a weld or bond at a distal end, according to
an embodiment of the invention;
[0090] FIG. 26B illustrates a cross-sectional side view of a
re-collapsible introducer wherein the side balloon has been folded
over at the distal end of the sheath to form a double balloon
stacked radially away from the axis of the sheath, according to an
embodiment of the invention;
[0091] FIG. 27A illustrates a cross-sectional end view of a distal,
collapsible end of a sheath that is fully expanded, wherein the
sheath includes a sheath wall and an outer pressure jacket,
according to an embodiment of the invention;
[0092] FIG. 27B illustrates a cross-sectional end view of the
distal, collapsible end of the sheath of FIG. 27A wherein the
region between the outer pressure jacket and the sheath wall has
been pressurized to collapse the sheath wall, according to an
embodiment of the invention;
[0093] FIG. 27C illustrates a cross-sectional end view of the
distal, collapsible end of the sheath of FIGS. 27A and 27B wherein
the region between the outer pressure jacket and the sheath wall
has been evacuated to collapse the outer pressure jacket and sheath
exterior, according to an embodiment of the invention;
[0094] FIG. 28A illustrates a cross-sectional end view of a distal,
collapsible end of a fully expanded sheath that includes a sheath
wall, a side-balloon, and an outer pressure jacket, according to an
embodiment of the invention;
[0095] FIG. 28B illustrates a cross-sectional end view of the
distal, collapsible end of the sheath of FIG. 28A, wherein the
side-balloon has been pressurized and expanded to collapse the
sheath wall, according to an embodiment of the invention;
[0096] FIG. 28C illustrates a cross-sectional end view of the
distal, collapsible end of the sheath of FIGS. 28A and 28B, wherein
the side-balloon has been evacuated and collapsed, according to an
embodiment of the invention;
[0097] FIG. 28D illustrates a cross-sectional end view of the
distal, collapsible end of the sheath of FIG. 28C, wherein the
region between the side-balloon and the pressure jacket has been
evacuated causing the pressure jacket to collapse, according to an
embodiment of the invention;
[0098] FIG. 29 illustrates a cross-sectional exploded side view of
a sheath hub and the internal components that provide for
hemostasis during and following introduction of catheters or
instruments therethrough, according to an embodiment of the
invention; and
[0099] FIG. 30 illustrates cross-sectional exploded side views of
alternative embodiments of the components within the sheath hub,
according to an embodiment of the invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0100] As used herein, the terms proximal and distal refer to
directions or positions along a longitudinal axis of a catheter or
medical instrument. Proximal refers to the end of the catheter or
medical instrument closest to the operator, while distal refers to
the end of the catheter or medical instrument closest to the
patient. For example, a first point is proximal to a second point
if it is closer to the operator end of the catheter or medical
instrument than the second point. However, the terms anatomically
proximal and anatomically distal refer to orientations within the
body. A point is more anatomically distal if it is further from the
heart than a point described as anatomically proximal.
[0101] FIG. 1 is a schematic frontal (anterior) illustration
(looking posteriorly) of a human patient 100 that illustrates
components of the central circulation. As shown, the central
circulation generally includes a heart 102, an aortic bifurcation
104, a descending aorta 106, an aortic arch 108, an inferior vena
cava 114, a superior vena cava 116, an iliac artery 112, a femoral
artery 110, and a thoracic aorta 118. In this illustration, the
left anatomical side of the body of the patient 100 is toward the
right of the illustration. FIG. 1 primarily illustrates components
of the central circulation.
[0102] Referring to FIG. 1, the heart 102 is a pump, the outlet of
which is the aorta, including the aortic arch 108, the thoracic
aorta 118, the descending aorta 106, and the aortic bifurcation
104, which include the primary artery in the systemic circulation.
The circulatory system, which is operably connected to the heart
102 further includes the return, or venous, circulation. The venous
circulation includes the superior vena cava 116 and the inferior
vena cava 114, which return blood from the upper extremities and
lower extremities, respectively. The iliac arteries 112 are
operably connected to, and receive blood from, the aortic
bifurcation 104. The femoral arteries 110, are operably connected
to, and receive blood from, the iliac arteries 112. The veins,
which terminate in the superior vena cava 116 and the inferior vena
cava 114, carry blood from the tissues of the body back to the
right heart, which then pumps the blood through the lungs and back
into the left heart. Pressures within the venous circulation
generally average 20 mm Hg or less. The arteries of the circulatory
system carry oxygenated blood (not shown) from the left ventricle
of the heart 102 to the tissues of the body 100. The pressures
within the aorta undulate, with a modified triangle waveform,
between diastolic pressures of around 80 mm Hg to a systolic
pressure of around 120 mm Hg. A hypotensive person may have
arterial pressure lower than 120/80 mm Hg and a hypertensive person
may have arterial pressures higher than 120/80 mm Hg. Systolic
arterial pressures of about 300 mm Hg, or greater, can occur in
extremely hypertensive persons.
[0103] FIG. 2 is a schematic frontal illustration, looking
posteriorly from the anterior side, of the patient 100. In this
illustration, much of the right ventricle, left ventricle, and left
atrium have been cut away to permit visibility of the thoracic
aortic structure 118, which lies posterior to the heart 102. A
hollow, 18-gauge needle 208 has been inserted into the left iliac
artery 112 via a percutaneous puncture or incision. A guidewire 210
has been inserted through the hollow, 18 gauge needle 208 and
routed, cranially, through the aortic bifurcation 104, up the
descending aorta 106 past the renal arteries 204, through the
thoracic aorta 118, and into the aortic arch 108. In this
illustration, the left anatomical side of the patient 100 is toward
the right. The guidewire 210 has been placed so that it can be used
to track therapeutic or diagnostic catheters into a region of the
thoracic aorta 118.
[0104] Referring to FIG. 2, the central arterial circulation,
through which the guidewire 210 has been routed, may range from 60
to over 300 mm Hg depending on the level of hypertension or
hypotension existent in the patient. By accessing the heart through
the arterial circulation, the chance of hemorrhage from the
catheter insertion site can be minimized by use of hemostasis
valves built into any catheters, sheaths, hollow needles, or
introducers 208 used on the patient. The guidewire 210 can
generally be of sufficient length that a portion of it extends
outside the body. Thus, the guidewire can be as long as, or longer
than, twice the distance to the treatment site in the patient 100.
The most commonly used guidewire diameter ranges from 0.032 inches
to 0.038 inches or larger for these applications. Guidewires can be
PTFE coated to improve lubricity and can have various types of tip
configurations including, but not limited to, straight, "J", floppy
tip, rigid tip, or the like. Access, in this illustration is gained
through the iliac artery 112 but, if the catheters are small
enough, the access can be gained through a femoral artery 110. As
will be described in more detail below, in some embodiments, access
can also be gained through the subclavian artery using a somewhat
shorter device.
[0105] FIG. 3A illustrates one embodiment of an expandable iliac
introduction sheath/dilator assembly 300. In the illustrated
embodiment, the assembly 300 includes three distinct regions of
expandability distributed along the length of the sheath. As will
be explained below, the assembly may have more or less distinct
regions of expandability. In some embodiments, the sheath/dilator
assembly 300 can include a sheath hub 302 further including a
Tuohy-Borst type hemostasis valve 340 (or any other type of
suitable hemostasis valve), a dilator hub 304, a proximal
non-expandable tubing region 306, a first transition zone 308, a
proximal expandable region 310, a central expandable region 312, a
distal expandable region 314, a second transition zone 320, a third
transition zone 322, a dilator balloon 318, and a length of dilator
catheter tubing 316.
[0106] Referring to FIG. 3A, the sheath hub 302 can be coupled to
the proximal end of the non-expandable tubing region 306. The
distal end of the non-expandable tubing region can be coupled to
the proximal end of the proximal expandable region 310 by the first
transition zone 308. The distal end of the proximal expandable
region 310 can be coupled to the central expandable region 312 by
the second transition zone 320. The distal end of the central
expandable region 312 can be coupled to the proximal end of the
distal expandable region 314 by the third transition zone 322. The
dilator balloon 422 (FIG. 4C) can be bonded, welded, or otherwise
coupled to the dilator catheter tubing 316 by balloon bonds (not
shown) at both ends of the dilator balloon 318. In some
embodiments, the dilator balloon 422 can be fully deflated and
wrapped around the dilator catheter tubing 316 prior to insertion
inside the sheath. The dilator hub 304 can be coupled to the
proximal end of the dilator catheter tubing 316.
[0107] FIG. 3B illustrates the expandable introduction sheath 330
(in an expanded configuration), which can be part of the
sheath/dilator system 300, but with the dilator removed. The
introduction sheath 330 includes the sheath hub 302, further
including the hemostasis valve 340, the proximal non-expandable
tubing region 306, the first transition zone 308, the proximal
expandable region 310, the central expandable region 312, the
distal expandable region 314, the second transition zone 320, and
the third transition zone 322.
[0108] Referring to FIG. 3B, the expandable introduction sheath 330
can be illustrated with the proximal expandable region 310, the
first transition zone 308, the second transition zone 320, the
central expandable region 312, the third transition zone 322, and
the distal expandable region 314 all having been expanded radially,
or diametrically, to a second, larger cross-sectional
configuration. Malleable reinforcing structures (not shown), which
will be described in more detail below, within the first transition
zone 308, the proximal expandable region 310, and the distal
expandable region 314 can maintain the sheath in the second,
larger, cross-sectional configuration. Preferably, the malleable
elements within the proximal expandable region 310 and the distal
expandable region 314 can maintain sufficient strength to overcome
resilient forces exerted by the polymeric tubing within which the
malleable elements can be embedded, but can have insufficient
strength to overcome the expansion forces of the dilator balloon
318 of FIG. 3A. The malleable reinforcing elements in the distal
expandable region 314 can, in some embodiments, provide similar
strength as those reinforcing elements in the proximal expandable
region 310. In some embodiments, the distal expandable region 314
can include reinforcing elements that are less strong than those in
the proximal expandable region 310. The reinforcing elements can
include structures such as, but not limited to, spiral windings of
flat or round wire, braided elements of polymeric strands, wire, a
mesh structure similar to a stent, a slotted tube with overlapping
longitudinally oriented slots, or the like.
[0109] The dilator balloon 318 can be fabricated from PET, PETG,
polyamide, polyamide, or the like, with wall thickness ranging
between 0.001 to 0.006 inches, and can be capable of containing an
internal pressure of 10 to 30 atmospheres, or higher. The dilator
balloon 318 can be generally filled with incompressible fluid such
as, but not limited to, saline, radiographic contrast media, or the
like by the operator, through a balloon inflation port integral to,
or coupled to, the dilator hub 304.
[0110] In some embodiments, the central expandable region 312 can
include reinforcing elements similar to those used in the proximal
expandable region 310 and the distal expandable region 314. In some
embodiments, the central expandable region 312, and the distal
expandable region 314 can include shape-memory reinforcing elements
that can be heated or cooled to generate austenite or martensite
conditions, respectively, that further can be used to drive the
sheath wall from one cross-sectional configuration to another.
[0111] FIG. 4A illustrates an embodiment of an expandable iliac
introducer sheath/dilator assembly 400 having only one region of
expandability. The expandable region 408 and the transition zone
406 can illustrated in a first, smaller cross-sectional
configuration. The transition zone 406 can form a taper between the
diametrically collapsed expandable region 408 and the larger
proximal non-expandable region 404. The introducer sheath/dilator
assembly 400 of the illustrated embodiment includes a sheath hub
402, a length of proximal non-expandable tubing 404, a transition
zone 406, an expandable region 408, the dilator balloon 318, the
length of dilator tubing 316, and the dilator hub 304.
[0112] Referring to FIG. 4A, the sheath hub 402 can be coupled to
the proximal end of the proximal non-expandable tubing 404. The
distal end of the proximal non-expandable tubing 404 can be coupled
to the proximal end of the expandable region 408 by the transition
zone 406. The dilator hub 304, dilator tubing 316, and dilator
balloon 422 (FIG. 4C) can be assembled as described in FIG. 3A.
[0113] FIG. 4B illustrates the expandable introduction sheath 430,
which can be part of the sheath/dilator system 400, but with the
dilator removed. The expandable region 408 and the transition zone
406 have been fully expanded to the second, larger, cross-sectional
configuration. The introduction sheath 430 includes the sheath hub
402, the proximal non-expandable tubing region 404, the first
transition zone 406, and the expandable region 408.
[0114] FIG. 4C illustrates a sheath dilator 400 including a dilator
shaft 420, the dilator hub 304, the dilator balloon 422, the distal
fairing 318, and the sheath distal tubing 316. The dilator balloon
422 includes neck down regions and the dilator balloon can be
coupled to the dilator shaft 420 or the dilator hub 304 at the
proximal neck down region and to the sheath distal tubing 316 at
the distal neck down region using adhesives, welding, or a
combination thereof. The dilator balloon 422 can be an angioplasty
type balloon fabricated from material such as, but not limited to,
PET, polyimide, polyamide, reinforced polymers, or the like. The
dilator balloon 422 can be configured to generate pressures ranging
up to 25 or 30 atmospheres when filled with pressurized liquids
such as, but not limited to, radiopaque dye contrast media, saline,
Ringer's lactate, or the like. The dilator balloon 422 includes a
flat length at least as long as the combined length of the sheath
expandable distal region 408 and the transition zone 406, and can
preferably be somewhat longer to facilitate manufacturability and
reliability. The dilator balloon 422 can include an inflated
diameter approximately equal to or slightly greater than that of
the fully expanded distal region 408 of the sheath. The balloon 422
can include wall thicknesses ranging from 0.0005 to 0.005 inches
and more preferably ranging between 0.0007 and 0.002 inches. Note
that the distal fairing 318, which can be beneficially fabricated
from soft elastomeric materials, can expand and fold distally off
the shoulders of the balloon 422 such that when the balloon 422 is
deflated, the fairing 318 can return to a small diameter that can
be withdrawn proximally through the lumen of the sheath 430.
[0115] FIG. 5A illustrates an embodiment of a two-way expandable
sheath dilator assembly 500 capable of being radially expanded and
then radially constricted prior to removal from the patient. The
sheath dilator assembly 500 includes the dilator hub 304, the
dilator balloon 422, the length of dilator tubing 316, the sheath
hub 502, the proximal sheath tubing 504, the transition zone 506,
and the expandable sheath region 508.
[0116] Referring to FIG. 5A, the sheath hub 502 can be coupled to
the proximal end of the proximal sheath tubing 504. The distal end
of the proximal sheath tubing 504 can be coupled to the proximal
end of the expandable region 508 by the transition zone 506. The
dilator hub 304, dilator tubing 316, and dilator balloon 318 can be
assembled as described in FIG. 3A.
[0117] The expandable region 508, in the illustrated embodiment,
can include shape memory elements (not shown) fabricated from
nitinol, which can be configured with an austenite finish
temperature in excess of body temperature (normally around 37
degrees centigrade). Thus, the expandable region 508 can be heated
by application of electricity to generate resistive heating and
temperature increase to above the austenite finish temperature. A
suitable austenite finish temperature can range from 38 to 50
degrees centigrade. Such heating can be performed at the conclusion
of the procedure, following removal of any therapeutic or
diagnostic instruments from the center of the sheath. The sheath
can generally be within the blood stream and not touching any
vascular walls. Furthermore, flowing blood can disperse heat
generated by the resistive heating elements so as to minimize
localized heating damage effects to the body. The shape memory
elements can be heat set to a collapsed, small diameter
configuration to which they can be biased following application of
resistive heating. The reinforcing structures can be configured as
a braid, a spiral winding, a woven mesh, a slotted tube, or the
like. The reinforcing structures can be heat set in a collapsed, or
small, initial diameter configuration and then be cooled to below
martensite finish temperature, at which point the reinforcing
structures can be expanded for coating with a polymer or other
suitable manufacturing process.
[0118] FIG. 5B illustrates the two-way expandable sheath dilator
assembly 500 with the dilator balloon 318 fully inflated to expand
the sheath radially, or diametrically, outward. The dilator balloon
318 can run the entire length and slightly beyond the extents of
the expandable region 508. The sheath dilator assembly 500 further
includes the expandable region 508, the transition zone 506, the
proximal non-expandable sheath tubing 504, the sheath hub 502, and
the length of dilator tubing 316.
[0119] FIG. 5C illustrates a two-way expandable sheath 530, which
is the sheath/dilator assembly 500 following removal of the
dilator. The two-way expandable sheath 530 includes the proximal
tubing 504, the hub 502, the transition zone 506, and the
expandable region 508. The expandable region 508 is illustrated
radially collapsed following removal of the balloon dilator.
[0120] Referring to FIG. 5C, the expandable region 508 can
re-collapse to a third, smaller cross-sectional configuration by
application of heat to the shape-memory reinforcement embedded
within the expandable region. The expandable region 508 can be made
to uniformly compress to a smaller diameter, or it can be made to
fold into any of a variety of cross-sectional patterns exhibited by
a tube that is folded along longitudinally disposed folds. In some
embodiments, where uniform reduction in cross-sectional shape is
imparted, the reinforcement can include a braid that elongates
longitudinally when reduced in diameter. The polymeric surround of
the expandable region 508 can preferably be elastomeric and
includes materials such as, but not limited to, polyurethane,
thermoplastic elastomer, silicone elastomer, or the like. The
interior of the wall of the expandable region can advantageously be
coated with a layer of high lubricity and low friction to
facilitate catheter or device introduction therethrough without
hang-up.
[0121] In some embodiments, the expandable region 508 can be
maintained with an open inner lumen if a hollow sleeve or dilator
(not shown) is inserted therethrough, or if the expandable region
508 has at least some hoop strength gained by appropriate wall
design or reinforcement within the wall. Referring to FIG. 5C, the
hollow sleeve or dilator (not shown) can include a hollow axially
elongate tube with a proximal end and a distal end. The tube can
include structures and materials that impart flexibility to the
hollow sleeve or dilator but the tube advantageously includes the
properties of column strength and kink-resistance. The proximal end
of the tube including the hollow sleeve or dilator can be coupled
to a sleeve hub. The structure of the tube comprised by the hollow
sleeve or dilator can preferably be very thin and can further
include a single material, preferably polymeric, or it can include
a built-up, composite structure with a reinforcing layer and a
polymeric surround. The reinforcing layer can include a braid,
weave, helical coil, slotted tube, or the like. In a preferred
embodiment, the hollow sleeve or dilator tube can include polymeric
surround materials such as, but not limited to, polyamide,
polyamide, polyurethane, polyester, polyether ether ketone, Hytrel,
or the like. The length of the hollow sleeve or dilator tube can be
sufficient to extend from the proximal end of the sheath hub 502 to
the distal end of the expandable region 508. The distal end of the
hollow sleeve or dilator tube can include a bevel on the outer
surface to assist with coercing the sheath expandable region 508 to
expand from the first, smaller cross-sectional area to the second,
larger cross-sectional area. The distal end of the hollow sleeve or
dilator tube can further include shape-memory elements that can be
bent radially inward at the distal end in their martensitic phase
and then, upon exposure to body temperature blood, the shape-memory
elements can expand radially outward to form a straight,
non-inwardly beveled distal end. In some embodiments, an obturator
can be provided which closely fits the inside diameter of the
hollow sleeve or dilator tube and which includes a tapered distal
end suitable for advancement into a body lumen, vessel, or
expandable sheath tube. The hollow sleeve or dilator tube can be
advanced into the expandable sheath as a unit. The obturator can
include a hub at the proximal end that can releasably snap or
connect to the distal end of the hollow sleeve or dilator tube hub.
Once the composite structure is advanced completely into the
expandable sheath, the obturator can be removed, revealing the
large central lumen suitable for the introduction of catheters,
instruments, implants, or the like.
[0122] FIG. 6A illustrates an embodiment of the iliac sheath system
600 including a dilator 400 further including a distal fairing 318,
a main dilator tube 330, an optional outer dilator tube (not
shown), a dilator balloon 422, a dilator hub 304 further including
an inflation port 332, and a sheath 630 further including a
proximal sheath tube 604, a transition zone 606, a distal sheath
tube 608, and a sheath hub 602. A guidewire 210 can be slidably
disposed within an inner lumen of the dilator 400.
[0123] Referring to FIG. 6A, the distal fairing 318 can be coupled
to the main shaft 330 of the dilator 400 near the distal end. The
distal fairing 318 can be fabricated from elastomeric materials
such as, but not limited to, thermoplastic elastomer, silicone
elastomer, polyurethane elastomer, Hytrel elastomer, or the like. A
balloon (not shown) can reside with the flat length disposed along
at least the entire distal sheath tube 608 and the transition zone
606. The balloon (not shown) can be coupled to the main shaft 330
of the dilator 400 and the interior of the balloon (not shown) can
be operably connected to an annulus running between the main shaft
330 and an external shaft (not shown) or within a lumen of the main
shaft 330. The annulus (not shown) or lumen (not shown) can
operably extend between the inflation port 332 and a skive, scythe,
or port opening into the interior of the balloon (not shown). The
balloon (not shown) can preferably be an angioplasty-type
non-elastomeric balloon fabricated from material such as, but not
limited to, PET, PET copolymers, polyamide, polyimide, reinforced
polymers, and the like. The balloon (not shown) can have a wall
thickness that can range between approximately 0.0004 and 0.005
inches, and more preferably between 0.001 and 0.002 inches. The
ends of the balloon (not shown) can be tapered inward to form
shoulders (not shown) that can be bonded, welded, or otherwise
coupled to the main shaft 330 at the distal end and either the main
shaft 330 or an external shaft (not shown) at the proximal end. The
dilator hub 304 can include an inflation port 332 that can be
operably connected to the inflation lumen or annulus of the dilator
400. In some embodiments, the proximal end of the dilator balloon
422 (FIG. 4C) can extend proximally all the way to the dilator
sidearm or hub 304. In some embodiments, fluid pressure applied to
an inflation port on the dilator hub 304 can be operably connected
to the annulus between the dilator balloon 422 and the catheter
shaft, allowing balloon inflation fluid such as radiopaque dye
contrast media, saline, or the like, to be routed into the balloon
internal structure and causing the balloon to forcibly expand
diametrically. This arrangement can result in a beneficial increase
in rated balloon burst, or inflation, pressure. Rated balloon burst
pressures in excess of about 25 to 30 atmospheres can be achieved
with 99.9% reliability and 95% confidence.
[0124] The dilator 400 (FIG. 4C) can be slidably disposed within
the central lumen of the sheath 630 and further includes an
expandable dilator (not shown) such as, but not limited to, an
angioplasty type balloon, malecot, reverse collet, or other device
capable of expansion to approximately 0.2-mm (0.5 French), or
greater, larger than the diameter of the sheath. The balloon (not
shown) can be inflated through the inflation lumen within the
catheter shaft, which can be operably connected, at the proximal
end, to a dilator hub or inflation port. Following inflation, which
expands the distal end of the sheath, the dilator expansion
element, such as the balloon (not shown), can be deflated or
collapsed, following which it can be removed from the sheath 630
along with the nose cone 318.
[0125] The sheath hub 602 can include ports that further include,
or can be terminated by, hemostasis valves. The hemostasis valves
can be configured to prevent hemorrhage from, or air intake into,
the lumen of the sheath 630. The hemostasis valves can include
between one and 5 elements to form a seal against nothing inserted
into the valve, form a seal against a maximum diameter object
inserted through the valve, and form a seal against anything of
intermediate size inserted through the valve. The hemostasis valve
elements can be fabricated from soft silicone or other elastomer.
The hemostasis valve elements can be coated or impregnated with
lubricious coatings such as silicone oil or hydrophilic layer. The
hemostasis valve elements can include duckbill valves, pinhole
valves, slit valves, X-slit valves, ring seals, or the like.
[0126] The distal sheath tubing 608 can be folded longitudinally in
a carefully predetermined pattern including between one and four
exterior fold edges, wherein the folds can extend all the way from
the proximal end of the transition zone 606 to the distal end of
the distal sheath tube 608. The distal fairing 318 can be
configured to cover the distal exposed edge of the distal sheath
tube 608 to provide a smooth taper against which the sheath system
600 can be advanced into the vasculature.
[0127] FIG. 6B illustrates the iliac sheath 630 following expansion
of the distal region 608 and removal of the dilator 400 and the
guidewire 316 of FIG. 6A. The proximal sheath tube 604, which can
be coupled at the proximal end to the sheath hub 602, can include
one or two layers of mesh reinforcement 612 and a spring-coil
reinforcement 610. The distal sheath tube 608 and the transition
zone 606 can further include a malleable coil 614 and, optionally,
the mesh reinforcement 612. The entire sheath tube, which includes
a central lumen (not shown), includes an approximately constant
inner diameter along the entire length. The approximately constant
diameter is beneficial in that objects of large diameter can be
inserted and advanced completely from the proximal end and out the
distal end of the sheath 630. The sheath 630 is illustrated in
partial breakaway view to show the coil reinforcement layers 610
and 614 along with the mesh 610.
[0128] In some embodiments, an inner sheath layer 634 can be first
laid down over a PTFE-coated stainless steel mandrel (not shown).
The sheath inner layer 634 can be preferably fabricated from
lubricious materials such as, but not limited to, polyethylene,
HDPE, LDPE, blends of HDPE and LDPE, PTFE, FEP, PFA, Hytrel, Pebax,
or the like. The sheath inner layer 634 can also be coated, on the
inner surface, with friction retarding materials such as, but not
limited to, silicone oil, polyurethane-based hydrophilic slip
coating materials, or the like. The optional mesh layer 612 can
next be applied over the inner layer 634. The coil reinforcement
layers 610 and 614 can next be applied over the mesh 612. In some
embodiments, a second layer of mesh can optionally be applied over
the coil 614. The second layer of mesh can have different
properties from the inner layer of mesh, including different
filament diameter, filament count, number of picks, and filament
density or angle. Finally, an outer layer 632 of polymeric material
can be applied over the reinforcement, after which shrink tubing
can be placed around the entire structure and can be heated to
shrink, melt, fuse, and bond the inner layer to the outer layer
while sandwiching the reinforcing layers therebetween. The sheath
inner layer 634 can have a wall thickness ranging between about
0.001 and 0.010 inches with a preferred range of about 0.002 and
0.006 inches. The sheath outer layer 632 can have a wall thickness
ranging between about 0.001 and 0.010 inches with a preferred range
of about 0.001 to 0.006 inches.
[0129] The mesh 612 can be formed from a braid, weave, knit or
other structure formed into a tubular cross-section. The mesh 612
can be fabricated from flat or round strands. The mesh 612 can be
fabricated from polymers such as, but not limited to, polyethylene
naphthalate (PEN), PET, polyamide, polyimide, or the like. The mesh
612 can also be fabricated from metals such as, but not limited to,
malleable stainless steel, spring stainless steel, nitinol,
titanium, cobalt nickel alloy, tantalum, gold, platinum, platinum
alloy, and the like. The lateral size of the strands of the mesh
612 can range between 0.001 and 0.010 inches in at least one
dimension. The number of ends of the mesh can range between 2 and
50.
[0130] The construction of the distal sheath tube 608 can include a
coil of wire 614 with a wire diameter of 0.001 to 0.040 inches in
diameter and preferably between 0.002 and 0.010 inches in diameter.
The coil 614 can also include a ribbon wire or a flat wire that can
be 0.001 to 0.010 inches in one dimension and 0.004 to 0.040 inches
in the other dimension. Preferably, the flat wire can be 0.001 to
0.005 inches in the small dimension, generally oriented in the
radial direction of the coil, and 0.005 to 0.020 inches in width,
oriented perpendicular to the radial direction of the coil. The
pitch of the coil 614, which is related to the spacing between coil
turns, can range from about 0 to about 5 times the ribbon width or
wire diameter. Preferably, some space exists between the coil turns
to permit bonding between the outer layer 632 and the inner layer
634 so a preferred spacing can be between 0.5 and 4 times the width
of the ribbon. The outer layer 632 of polymeric material can have a
wall thickness of 0.001 to 0.020 inches and the inner layer 614 has
a wall thickness of between 0.001 and 0.010 inches. The wire used
to fabricate the coil 614 can be fabricated from annealed materials
such as, but not limited to, gold, stainless steel, titanium,
tantalum, nickel-titanium alloy, cobalt nickel alloy, or the like.
The wire can preferably be fully annealed. The wires can also
include polymers or non-metallic materials such as, but not limited
to, PET, PEN, polyamide, polycarbonate, glass-filled polycarbonate,
carbon fibers, or the like. The wires of the coil reinforcement can
be advantageously coated with materials that have increased
radiopacity to allow for improved visibility under fluoroscopy or
X-ray visualization. The radiopaque coatings for the coil
reinforcement may include gold, platinum, tantalum,
platinum-iridium, or the like. The mechanical properties of the
coil can be such that the coil is able to control the configuration
of the fused inner layer 634 and the outer layer 632.
[0131] When the distal region 608 is folded (see description below
with reference to FIGS. 14A and 14B) to form a small diameter, the
polymeric layers 634, 632, which can have some memory, do not
generate significant or substantial springback. The sheath wall can
preferably be thin so that any forces it imparts to the tubular
structure can be exceeded by those forces exerted by the malleable
distal reinforcing layers 614, 632. Additionally, a peel away,
slide away, or otherwise removable protective sleeve (not shown)
can be useful, but not necessary, to maintain the collapsed sheath
configuration.
[0132] FIG. 6C illustrates the sheath 630 having been expanded
diametrically in a prior step, with a prosthetic heart valve
delivery catheter 622 shaft inserted therethrough. A prosthetic
heart valve 620 can be coupled to the delivery catheter shaft 622
near or at the distal end of the catheter shaft 622. The delivery
catheter shaft 622 further includes a hub 624, which can be coupled
to the proximal end of the delivery catheter shaft 622, and a
balloon inflation sidearm port 626. The central port, at the
proximal end of the hub, can preferably be terminated by, or
includes, a hemostasis valve. The hemostasis valve can be
configured to prevent hemorrhage from, or air intake into, the
valve delivery catheter.
[0133] It should be appreciated that modifications thereof can be
used to provide an expandable region of the catheter with an
initial small cross-sectional diameter. By unfolding the distal
region 1400, the diameter of the distal region is increased to a
larger diameter. In the smaller folded configuration, the malleable
structures described above can maintain the distal region in the
smaller folded configuration. In some embodiments, an external
structure can maintain the sheath in the folded configuration. In
this smaller folded configuration it has been noted that the
flexibility of the catheter (e.g., the ability of the catheter to
navigate the aortic arch) can be increased. When the catheter is
unfolded and expanded, the malleable structure can reform to the
larger unfolded diameter and to the shape of the anatomy (e.g., the
aortic arch) in which the sheath his placed. In the unfolded
configuration, the malleable structures can provide hoop strength
to maintain the patency of the lumen.
[0134] In some embodiments, the exterior of the sheath, and
optionally the internal lumen of the sheath, can be coated with a
lubricious coating including materials such as, but not limited to,
silicone oil or a hydrophilic hydrogel including polyethylene
glycol, polyether polyurethane, or the like. Other coatings can
include antimicrobial coatings such as those fabricated from silver
azide or anticoagulant coatings such as those including
heparin.
[0135] In the illustrated embodiment of FIG. 6C, the prosthetic
valve delivery catheter 622 can be configured to deliver the
collapsed prosthetic valve 620 to an implantation site within the
patient. Typical valves include aortic and mitral valve
replacements. The prosthetic valve 620 further includes an
expandable stent support and fixation elements. The valving element
can be suspended within, or around, the expandable stent and can
include between one and four leaflets fabricated from polyurethane,
cross-linked pericardium, fixed natural porcine aortic roots, or
homografts. The outside diameter of the collapsed prosthetic valve
620 can be such that the valve 620 can be slidably advanced through
the lumen of the sheath 630. In some embodiments, the valve
delivery catheter can include an external sleeve to retain the
valve 620 in the smallest possible diameter during placement into
the patient. The expandable stent support can be malleable and
balloon expandable, self-expanding, or self expanding with balloon
expansion augmentation.
[0136] FIG. 7 illustrates an expandable iliac sheath 700 having
been inserted into the femoral artery 112 of a patient 100. The
expandable iliac sheath 700 includes the proximal sheath tube 604,
the distal sheath tube 608, the sheath hub 702, a dilator further
including a dilator hub 304, the dilator nose fairing 318, and a
guidewire 210. The patient 100 further includes the descending
aorta 106, and the aortic arch 108.
[0137] Referring to FIG. 7, the sheath hub 702 can be a single
lumen hub with a large hemostasis valve and a purge port. The
sheath hub 702 can be coupled to the proximal end of the proximal
sheath tubing 604. In the illustrated embodiment, the distal end of
the distal sheath tube 608 can be advanced at least past the aortic
bifurcation and can be advanced as far as across the aortic arch
108 and just downstream of, or through, the aortic valve. The
distal sheath tube 608 and the dilator expandable component (not
shown), compressed within the distal sheath tube 608 are in the
first, small diameter configuration to permit maximum flexibility
and minimum profile, for negotiating the vasculature.
[0138] FIG. 8 illustrates that the expandable iliac sheath 700 can
have the distal tubing 608 diametrically expanded by the dilator,
which can be removed to reveal the large, through working lumen.
The expandable iliac sheath 700 includes the proximal sheath tube
604, the now dilated distal sheath tube 608, and a guidewire 210.
The patient 100 further includes the thoracic aorta 118, the
descending aorta 106, and the aortic arch 108.
[0139] Referring to FIG. 8, the guidewire 210 can remain in place
or can be withdrawn at this time, if appropriate to the procedure.
The expanded sheath can be inserted as shown or can be beneficially
advanced so that the distal end is just downstream of the aortic
valve.
[0140] FIG. 9 illustrates the expandable iliac sheath 700 with an
aortic valve delivery catheter 622 and prosthetic aortic valve 620
having been advanced therethrough. The guidewire 210 can remain in
place but can be removed, if desired. The prosthetic aortic valve
620 can be advanced toward the natural aortic root (not shown) 1022
and can be implanted therein.
[0141] FIG. 9 illustrates an embodiment in which the distal end of
the sheath is shown in the thoracic aorta 118 but is beneficially
located in the aortic arch 108 or proximate the aortic valve root
1022 for ease of delivery of the aortic valve prosthesis 620. The
aortic valve delivery catheter 622 can include a dilatation balloon
to expand the aortic valve prosthesis 620, dilate the diseased
natural aortic root 1022, and firmly implant the prosthesis 620
within the natural diseased aortic root 1022. Following
implantation of the prosthesis 620, a release mechanism, including
the catheter 622, can be activated to detach the prosthesis 620 so
the catheter 622 and the sheath 700 can be removed from the
patient. A hemostasis sheath (not shown) can be advanced into the
incision in the iliac artery to minimize loss of blood and
stabilize the patient during the immediate postoperative period.
The hemostasis sheath (not shown) can include a catheter tube
approximating the diameter of the proximal sheath tubing 604 along
with a hemostasis valve to prevent unwanted blood loss.
[0142] The hemostasis sheath (not shown), the guidewire 210, and
the sheath 700 can be provided in a kit, or packaged together for
the convenience of the user. All components can be sterilized using
ethylene oxide or radiation sterilization, the latter at dosages
of, for example, about 25 to 40 kGray. The components of the kit
can be packaged in a single aseptic or double aseptic packaging
system.
[0143] FIG. 10 illustrates an aortic sheath 1000 inserted into an
iliac artery and then routed, with the expandable distal end 1008
in the diametrically collapsed configuration, around the aortic
arch 108 and positioned just distal to the aortic valve 1020. The
natural aortic valve 1020 is situated within the aortic root 1022,
the aortic root 1022 further including three sinuses of Valsalva.
The heart is illustrated in partial cross-section. The guidewire
210 can extend through the aortic valve 1020 and into the left
ventricle.
[0144] Referring to FIG. 10, the aortic sheath 1000 can be
configured to reach from a femoral or iliac artery 112 access site
to the left ventricle of the heart. The proximal non-expandable
region 1004 can be maintained in position outside the patient 100
or it can be inserted into the femoral or iliac artery. The small
diameter of the distal expandable region 1008 can result in a
highly flexible configuration that is resistant to kinking because
the internal lumen is filled with the dilator. This configuration
can be routed around the aortic arch much more easily than another
catheter having a larger diameter, similar to that of the proximal
region of the catheter. The distal fairing, or nose cone 318, which
can be coupled to the dilator, can be situated just distal to the
aortic valve.
[0145] FIG. 11 illustrates the patient 100 wherein the sheath 1000
has had the expandable distal region 1008 expanded by the dilator
system, following which the dilator system 400 (Refer to FIG. 4C),
further including the dilator hub 304, has been removed. The
central lumen (not shown) of the sheath 1000 includes a relatively
large, constant diameter from the distal end to the proximal end of
the sheath hub 1002. The distal end of the sheath 1000 can be
situated within the aortic outflow tract, proximate the aortic
root, with the sheath 1000 having fully traversed the aorta and
aortic arch 108. In some embodiments, the distal region 1008 can be
routed through the aortic arch and then expanded to remodel the
walls of the expandable distal portion 1008 of the sheath 1000. In
the remodeled configuration, the distal expandable region 1008 can
exhibit greater stiffness, reduced flexibility, greater diameter,
and greater torqueability than the distal expandable region 1008 in
the unexpanded configuration, as illustrated in FIG. 10. The
remodeling generally is preferable to elastic deformation that can
cause the distal region 1008 of the sheath to spring or bias itself
straight, since the remodeling can result in a sheath that
generally takes on the curve to which it is pre-set prior to
expansion and to which the distal region 1008 is exposed during the
expansion procedure. The remodeling condition can occur because
balloon dilatation forces cause the plastic walls of the distal end
1008 of the sheath 1000 to plastically flow to their new
configuration prior to removal of the dilator. The reinforcement
within the distal, expandable region 1008 preferably does not
substantially contribute to bending forces on the expanded distal
section 1008.
[0146] FIG. 12 illustrates the patient 100 wherein a prosthetic
aortic heart valve replacement 620 is placed through the sheath
1000 by means of a catheter valve introducer 622. The catheter
valve introducer 622 can be placed through a hemostasis valve 1002
coupled at or near the proximal end of the sheath 1000. The sheath
1000 can facilitate introduction of the prosthetic valve 620 as
well as the removal, should that become necessary. The guidewire
210 can remain in place as a safety wire or it can be removed
during this part of the procedure. The distal expandable region
1008 of the sheath 1000 can be fully expanded, can be relatively
rigid compared to the collapsed configuration as illustrated in
FIG. 10, and can be less capable of being advanced through tortuous
vasculature than when it is in the un-dilated state.
[0147] FIG. 13 illustrates an expandable arterial access sheath
1300 being used to access the arterial vasculature through the left
subclavian artery 1316 of a human patient 100. The expandable
arterial access sheath 1300 enters the subclavian artery 1316 at
the arterial access site 1302. The sheath 1300 includes the
expandable distal region 1304, the transition zone 1306, the
proximal, non-expandable region 1308, the sheath hub 1310, and the
sheath hemostasis valve 1314. The sheath 1300 can be used to guide
a valve delivery catheter 1320 to the aortic outflow tract 1022
through the aortic arch 108 and proximate the natural aortic valve
1020. A guidewire 210 is illustrated passing through the central
lumen (not shown) of the valve delivery catheter 1320 with the
distal end of the guidewire 210 extending through the natural
aortic valve 1020 and into the left ventricle 1322. The valve
delivery catheter 1320 can be used to deliver, in retrograde
fashion, a prosthetic aortic valve 620, which is in the
diametrically collapsed, first configuration.
[0148] Referring to FIG. 13, the subclavian access configuration of
the expandable arterial access sheath 1300 can be shorter than a
trans-femoral device with a working length that can range between
25 and 50 cm. The same diameters and construction techniques used
for other devices described herein can be suitable for use in the
expandable subclavian access sheath 1300. It is generally
advantageous that the expandable distal region 1304 is inserted
into the arterial access site 1302 and advanced to a region just
downstream of, or through, the natural, diseased or damaged aortic
valve 1020. The transition zone 1306 and the proximal,
non-expandable region can advantageously reside outside the body
for the duration of the procedure such that no sheath axial
translation can occur after the expandable distal region 1304 has
been dilated or expanded.
[0149] FIG. 14A illustrates a lateral cross-section view of a
distal region 1400 of an expandable arterial sheath including a
wall 1402, a single longitudinally extending fold 1408 further
including an outside edge 1404 and an inside edge 1406, and a
plurality of electrical conductors running axially through the wall
1402. With a small diameter distal section 1400 and a relatively
thick wall 1402, a single fold 1408 is the one structure to create
during manufacturing. The sheath wall 1402 further includes an
optional electrical bus 1412 fabricated from stainless steel,
silver, copper, or other conductor metal for use in transmitting
electrical energy from the sheath hub (not shown) to distal regions
of the sheath for purposes such as resistive heating, steering, or
the like.
[0150] FIG. 14B illustrates another embodiment of a lateral
cross-section of a distal region 1420 of an expandable arterial
sheath including a wall 1422 further including a double
longitudinally extending fold 1428. The double fold 1428 further
includes two outside edges 1424 and two inside edges 1426 which
form longitudinal creases in the wall 1422. When the diameter of
the sheath increases, it can advantageously form a plurality of
folds in the wall 1422. For a sheath having a fully expanded
outside diameter ranging between 12 French and 30 French and with a
wall thickness ranging between 1 and 2-French, a double fold, as
illustrated in FIG. 14B can be preferred. A double fold, for
example, can allow a 14 French outside diameter sheath to fold into
a collapsed diameter of around 9 to 12 French. An 18-French outside
diameter sheath having a 1 to 2-French wall thickness can be folded
into a collapsed diameter of around 12 to 13 French using a double
fold. The sheath wall 1422 further includes an optional balloon
inflation lumen 1430 for use in transmitting fluidic pressure or
energy from the sheath hub to distal regions of the sheath wherein
a balloon may be coupled. The diameter of the balloon inflation
lumen 1430 can range between 0.005 to 0.025 inches. In some
embodiments, the number of folds can range in number between 3 and
10.
[0151] It should be appreciated in the embodiments described above
that the longitudinal folds of FIGS. 14A and 14B or modifications
thereof can be used to provide an expandable region of the catheter
(see embodiments of FIGS. 3A-13) with an initial small
cross-sectional diameter. By unfolding the distal region 1400, the
diameter of the distal region can be increased to a larger
diameter. In the smaller folded configuration, the malleable
structures described above can maintain the distal region in the
smaller folded configuration. In other embodiments, an external
structure can maintain the sheath in the folded configuration. In
this smaller folded configuration it has been noted that the
flexibility of the catheter (e.g., the ability of the catheter to
navigate the aortic arch) is increased. When the catheter is
unfolded and expanded, the malleable structure can reform to the
larger unfolded diameter and to the shape of the anatomy (e.g., the
aortic arch) in which the sheath is placed. In the unfolded
configuration, the malleable structures can provide hoop strength
and maintain the patency of the lumen.
[0152] FIG. 15 illustrates a short, expandable iliofemoral
introducer sheath 1500 advanced over a guidewire 210, through a
percutaneous access site 112, into the abdominal aorta 106 just
proximal to the aortic bifurcation 1504 in a patient 100 in the
first, radially collapsed configuration. The iliofemoral introducer
sheath 1500 includes a sheath hub 702, a short length of
non-collapsible proximal sheath tubing 604, a distal collapsible
region 608, a dilator 304, and a distal nose cone or fairing 318.
In some embodiments, the distal fairing 318 can reside anatomically
distal to the renal arteries 1502 but not be advanced as far as the
aortic arch 108 or even the thoracic aorta 118.
[0153] The introducer sheath 1500 can be radially expanded by
pressurizing the dilator 304 through a balloon inflation port on
the dilator 304, in the distal region 608 such that the internal
lumen of the distal region 608 can be similar to, or substantially
the same as, that of the non-expandable proximal region 604. The
dilator 304 can next be removed leaving the large internal lumen
within the introducer sheath 1500 for placement of catheters into
the aorta. Such catheters can include, but are not limited to, PTCA
catheters, stent delivery catheters, prosthetic heart valve
delivery catheters, abdominal aortic stent graft delivery
catheters, thoracic aorta stent-graft delivery catheters, or the
like.
[0154] FIG. 16a illustrates a short, expandable, re-collapsible
iliofemoral introducer sheath and dilator system 1600 in the first,
radially collapsed configuration. The re-collapsible introducer
sheath 1600 includes a sheath hub 1602 further including a sheath
collapse port 1616, a dilator 304 further including a dilator
balloon 318 and a length of dilator tubing 316, a proximal,
non-collapsible sheath tube 1604, a transition zone 1606, a distal
collapsible region 1608 further including at least one longitudinal
fold 1614, an outer pressurization jacket 1610 and an outer
pressurization jacket to sheath bond 1612.
[0155] Referring to FIG. 16a, the sheath and dilator system 1600
can be similar to the device illustrated in FIG. 6 except for the
presence of the external pressurization jacket 1610, which can be
coupled and sealed to the sheath tubing 1604 and 1608 at the
proximal and distal ends, respectively. A lumen (not shown) can
operably connect the collapse port 1616 to the gap between the
outer pressurization jacket 1610 and the sheath tubing 1608. The
proximal end of the external pressurization jacket 1610 can
preferably be coupled to the sheath tubing in the proximal
non-collapsible region 1604 or the transition zone 1606. The
external pressurization jacket 1610 can also be operably connected
to, or coupled to the sheath hub 1602 such that an annulus lumen
can exist between the inside of the jacket 1610 and the outside of
the sheath tubing 1604, 1606 allowing pressurized fluid to flow to
and from the gap between the jacket 1610 and the sheath tubing
1608, 1606. The pressurization jacket 1610 can be fabricated from
foldable materials that can be substantially non-distensible or
non-elastic such as, but not limited to, polyester, polyimide,
polyamide, irradiated polyethylene, or the like. The wall thickness
of the outer jacket 1610 can range between 0.0002 inches and 0.005
inches with a preferred wall thickness range of 0.004 and 0.0015
inches. Such structures for the pressurization jacket 1610 can be
substantially size constrained or limited and do not expand
excessively in their exterior dimensions.
[0156] In some embodiments, the outer jacket 1610 can include a
double layer of material such as a double layer of polyester (PET)
with wall thickness ranging between 0.0002 inches and 0.005 inches
with a preferred wall thickness range of 0.004 and 0.0015 inches.
The double layer is advantageous because it permits a strong
pressure seal to be created in a situation where such a seal might
not otherwise be possible given the dissimilar nature of the
material of the outer jacket 1610 and the sheath tubing 1604, 1606,
1608. The sheath tubing 1604, 1606, 1608 also, preferably includes
a malleable metal reinforcement layer embedded therein that can
control the shape of the sheath tubing when not being moved by the
dilator 304 or pressurization of the region interior to the outer
jacket 1610. Pressurization of the collapse pressurization port
1616 can be performed using a syringe, PTCA inflation device, or
the like at pressures ranging from about 1 to 30 atmospheres,
preferably between about 4 to 12 atmospheres and most preferably at
pressures ranging between about 6 to 10 atmospheres, using
non-compressible fluids such as saline, water, or radiopaque
contrast media.
[0157] FIG. 16b illustrates the expandable, re-collapsible
iliofemoral introducer 1600 in a second, radially expanded
configuration with the inflated dilator still in place. The outer
jacket 1610 can be expanded and unfolded with the sheath tubing
1608, 1606 to approximate the maximum profile. The dilator 304 and
the dilator balloon 318 remain in place within the sheath. The
sheath tubing 1604, 1606, 1608 can retain a generally continuous
profile and substantially continuous internal lumen (not shown) of
substantially the same size throughout, although some minor
distortions of the distal collapsible region 1608 can occur.
[0158] FIG. 16c illustrates the iliofemoral introducer 1600 with
the dilator 304 (see FIG. 16b) removed and the space 1618 between
an outer jacket 1610 and the introducer sheath 1608, 1606
pressurized through the port 1616, on the hub 1602, to collapse the
introducer sheath distal tube 1608 to the third, radially collapsed
configuration. The gap 1618 between the outer jacket 1610 and the
sheath tubing 1608 is visible in this illustration. The transition
zone 1606 can taper to the smaller diameter of the collapsed
distal, collapsible region 1608. Following completion of this
collapsing step by pressurization, the fluid can be withdrawn from
the gap 1618 and can thus cause the outer jacket 1610 to become
flaccid and at least partially collapse, thus facilitating removal
of the now smaller diameter sheath system 1600 from a patient.
[0159] FIG. 17a illustrates a collapsing obturator 1700 for use
with expandable introducer sheaths. The collapsing obturator 1700
includes a length of obturator tubing 1702, a hub 1722 further
including an evacuation port 1712, and a sealing balloon inflation
port 1714, a proximal sealing balloon 1708 having a plurality of
balloon bonds 1710, a distal sealing balloon 1706 including a
plurality of balloon bonds 1710, a plurality of evacuation vents
1704 and an inter-balloon evacuation region 1720.
[0160] Referring to FIG. 17a, the sealing balloons 1706 and 1708
can be elastomeric balloons fabricated from materials such as, but
not limited to, polyurethane, latex, silicone elastomer,
thermoplastic elastomer, or the like, or they can be substantially
inelastic balloons such as those fabricated from materials such as,
but not limited to, polyolefin, irradiated polyethylene, polyester
(PET), polyimide, polyamide, or the like. The proximal and distal
sealing balloons 1708, 1706, respectively, can further be coated
with conformable materials to improve sealing between the inflated
balloons 1708, 1706, and the inside wall of an inflated sheath
tube. Such coating (not shown) can include the same materials used
to fabricate the elastomeric balloons described herein. The coating
can further include hydrogel, or other gel-type substance.
[0161] The obturator tubing 1702 can include a multi-lumen
cross-section or can include an annular configuration having an
inner tube and an outer tube with an annular lumen therebetween to
operably transmit pressurized fluid to the interiors of the
balloons 1706, 1708 as well as evacuating the inter-balloon region
1720 through the one or more vents 1704. The balloon pressurization
port 1714 on the hub 1722 can be operably connected to a lumen and
thereby to the interior of the sealing balloons 1706, 1708 by a
pressurization vent or skive in the tubing wall 1702 under the
region of the balloons 1706, 1708. The evacuation port 1712 can be
operably connected to another, separate lumen within the tubing
1702, which can be further operably connected to the one or more
vent ports 1704 skived or cut into the tubing 1702 to operably
connect the evacuation lumen to the outside environment.
[0162] FIG. 17b illustrates the collapsing obturator 1700 having
been inserted into a diametrically expanded introducer sheath
further including the sheath hub 704, the transition zone tubing
406, and the distal sheath tubing 408, and then pressurized to
expand the two sealing balloons 1708, 1706. The proximal sealing
balloon 1708 can preferably reside within the proximal
non-expandable region of a sheath while the distal sealing balloon
1706 can preferably reside as close as possible to the distal end
of the sheath so as to provide some seal but permit the maximum
amount of sheath collapse proximal thereto. The inter-balloon
evacuation region 1720 can now define a sealed volume with the
outer boundary being the inside surface of the expanded sheath
distal tubing 408 and transition zone 406.
[0163] FIG. 17c illustrates the collapsing obturator 1700 within
the introducer sheath with the two sealing balloons 1706, 1708
inflated, and the evacuation region 1720, between the sealing
balloons but outside the collapsing obturator 1700, depressurized
to radially collapse the distal expandable introducer sheath tubing
408. A partial vacuum can be drawn in the evacuation region 1720,
by way of the evacuation port 1712, to collapse the outer sheath
tubing 408. Following such deflation, the sealing balloons 1706,
1708 can be deflated and the system can be removed from a patient
with less friction and potential for tissue trauma than a sheath
that is removed, fully expanded, or never collapsed. Note that a
portion of the distal most region of the sheath tubing 408 can
remain expanded where the expanded sealing balloon 1706 was located
during collapse. This short length of expanded sheath tubing 408 is
easier and less traumatic to remove than a longer length of
expanded sheath tubing 408. At the proximal end, the sealing
balloon 1708 can reside within the transition zone 406 or the
non-collapsible sheath tubing near the hub 704, which can be
outside the patient and so this has no effect on sheath removal.
The distal sealing balloon 1706 can function with a minimum of
about 0.100 inches of seal.
[0164] FIG. 18a illustrates an expanded view of the expandable,
re-collapsible introducer 1600 showing the inflation and deflation
lumen within a hub 1602 and outer jacket 1610. The introducer 1600
includes the sheath hub 1602, further including a central lumen
1806, a collapsing port 1616, and a collapsing lumen 1802, a
proximal non-expandable region 1604, a distal collapsible region
1608, the outer jacket 1610, a distal jacket to sheath bond 1612,
an annular gap 1618, and a collapsing lumen reinforcement 1804. The
collapsing lumen reinforcement 1804 can be a tube further including
a lumen that can be operably connected to the lumen 1802 within the
hub 1602, or it can be a groove, heat welded into the proximal
sheath tubing 1604, or the like. The reinforcement 1804 can be
non-perforated or it can be perforated with one or more skives,
windows, holes, or the like. The outer jacket 1610 can be a single
layer or it can include a double layer that can be everted,
adhesively adhered, or welded to itself at the distal end. The
double layer outer jacket 1610 can have the advantage of providing
a very strong bond and, thus improved inflation reliability, as
well as the ability to completely collapse the collapsible sheath
tubing 1608 substantially all the way to, and including, the distal
end of the collapsible sheath distal tubing 1608.
[0165] FIG. 18b illustrates a forming obturator 1800 in side view
configured to control the shape of the distal collapsible region
1608 of a sheath 1600. The forming obturator 1800 includes a handle
1810, a proximal portion 1812 having a substantially round
cross-section, a distal forming region 1814, and a nose cone 1816.
The round proximal portion 1812 can be configured to beneficially
seal within a hemostasis valve of a sheath hub 1602. The handle
1810 can be configured for manual grasping by the operator. The
forming obturator 1800 can preferably be fabricated from flexible
materials that can bend within the sheath 1600 but yet retain some
shape to help form the sheath distal region 1608 upon re-collapse.
The forming obturator 1800 can be a single integral structure or
the components can be coupled to one another. The forming obturator
1800 can be fabricated from materials such as, but not limited to,
stainless steel, polyethylene, polypropylene, silicone elastomer,
thermoplastic elastomer, polyurethane, polyacetal, or the like. The
forming obturator 1800, in the forming region 1814 can include
various cross-sectional shapes such as, but not limited to, a cross
(as illustrated), a three-blade propeller, a U, a W, a V, or the
like. The forming obturator 1800 can be configured to be removable
and reinserted into a sheath 1600 prior to re-collapse. The forming
obturator 1800 can further include a guidewire lumen (not shown)
having a diameter of about 0.020 to 0.060 inches. The forming
obturator 1800 can also be termed a collapsing obturator. The
forming obturator 1800 can help prevent the formation of large,
stiff wings in the distal collapsible region 1608 following
re-collapse.
[0166] FIG. 18c illustrates a cross-sectional view of another
embodiment of the forming region 1814' of a forming or collapsing
obturator 1800 having a three-pronged profile.
[0167] FIG. 18d illustrates a cross-sectional view of another
embodiment of the forming region 1814'' of a forming or collapsing
obturator 1800 having a splayed U configuration.
[0168] FIG. 19 illustrates an expandable, re-collapsible introducer
1900 that includes a non-removable self-expansion element. The
re-collapsible introducer 1900 includes a hub 1902 further
including a central port 1912 further including a hemostasis valve,
an expansion sideport 1904, a collapse sideport 1616, a length of
proximal sheath tubing 1604, a transition zone 1606, a collapsible
distal tube 1608, an outer jacket 1610 having a distal weld 1612,
and an internal, integral expansion dilator 1906.
[0169] Referring to FIG. 19, in which the introducer 1900 is shown
in the expanded configuration, the components, except for the
integral expansion dilator 1906 can be similar to the device
illustrated in FIGS. 18 and 16a-16c. The integral expansion dilator
1906 can be an annular balloon fabricated from the same materials
as those used in other dilators described herein. The integral
expansion dilator 1906 can be operably coupled to the expansion
sideport 1904 by a lumen (not shown) that can permit pressurized
fluid to enter the integral expansion dilator 1906 from the
expansion port 1904, when pressurized by an external inflation
device, syringe, or the like. When deflated, the integral expansion
dilator 1906 includes an annular central lumen capable of
permitting catheters and other instrumentation to be inserted
therethrough. The integral expansion dilator 1906 can be maintained
depressurized and out of the way through the use of a stopcock (not
shown) or other valve coupled to the expansion sideport 1904.
Collapse of the system can be accomplished by pressurizing the
collapse sideport 1616 to pressurize the gap between the outer
jacket 1610 and the sheath tube 1608. This collapse can preferably
be performed prior to sheath removal from the patient. This device
can be repeatedly expanded and collapsed, as needed, as can the
devices illustrated in FIGS. 18, 17a-17c, and 16a-16c.
[0170] FIG. 20 illustrates a side view, with breakaway in regions
distal to the sheath hub 2002, of a re-collapsible introducer 2000
including an outer pressure jacket 2012, a sheath wall 2008, the
sheath hub 2002 further including a purge port 2006, a collapse
port 2004, a proximal pressure jacket bond 2014, a distal pressure
jacket bond 2018, a central sheath lumen 2010, and a pressure
chamber 2016.
[0171] Referring to FIG. 20, the outer pressure jacket 2012 can be
coupled, at the proximal end to the sheath wall 2008 or the sheath
hub 2002 by the proximal pressure jacket bond 2014. The distal end
of the outer pressure jacket 2012 can be coupled to the sheath wall
2008 by the distal pressure jacket bond 2018. The proximal and
distal pressure jacket bonds, 2014 and 2018 respectively, can be
heat welds, solvent bonds, adhesive bonds, ultrasonic welds, or the
like. The outer pressure jacket 2012 can be fabricated from
polyester (PET), or other high strength polymer such as, but not
limited to, polyamide, polyimide, or the like. The thickness of the
outer pressure jacket 2012 can range from about 0.0001 inches to
about 0.002 inches and preferably between about 0.0002 to 0.001
inches. The sheath wall 2008 can be fabricated from polymeric
materials such as, but not limited to, polyester, polyimide,
polyethylene, polypropylene, Hytrel, Pebax, or the like. The sheath
can further include outer and inner layers and reinforcing layers
as described elsewhere within this specification. The collapse port
2004 can be operably coupled to the pressure chamber 2016 between
the sheath wall 2008 and the pressure jacket 2012 such that fluid
can communicate and be introduced or removed from the pressure
chamber 2016 by way of the collapse port 2004. In the illustrated
embodiment, the pressure chamber 2016 can surround the sheath wall
2008 and can be substantially coaxial thereto although at the
proximal end, some distortion of this coaxial alignment may be
required to form the proximal pressure jacket bond 2014. The distal
pressure jacket bond 2018 in the illustrated embodiment can be
coupled to the outside of the sheath tubing 2008 with no folding of
the pressure jacket 2012.
[0172] FIG. 21 illustrates a cross-sectional side view of the
distal end of a re-collapsible introducer or sheath 2100 that
includes the outer pressure jacket 2012, the pressure chamber 2016,
the sheath central lumen 2010, a sheath inner wall 2102, a sheath
outer wall 2104, a sheath reinforcement 2106, a distal pressure
jacket bond 2114, and a distal pressure jacket fold 2116.
[0173] Referring to FIG. 21, the outer pressure jacket 2012 can be
folded, at 2116, over the distal end of the sheath outer wall 2104
and sheath inner wall 2102 and welded or otherwise coupled to the
interior of the sheath inner wall 2102. The sheath inner wall 2102
and the sheath outer wall 2104 can be fused or welded together with
the sheath reinforcement 2106 embedded therein. In the illustrated
embodiment, the sheath inner wall 2102 can be Hytrel 55D, the
sheath outer wall can be Hytrel 40D, and the pressure jacket 2102
can be PET, however other polymers or hardnesses can be used to
achieve material and bond compatibility. The sheath reinforcement
can be a coil of 0.010 wide by 0.003 to 0.005 thick flat, annealed
stainless steel wire although other metals, levels of annealing,
and dimensions can be useful depending on the design of the sheath.
Advantageously, the pressure jacket bond 2114 can allow pressure to
be applied to the sheath wall structure 2102, 2104, 2106 all the
way to the distal end to force collapse or refolding whereas the
embodiment shown in FIG. 20 can include a bond region 2018 that may
not be pressurized or collapsed completely. Another advantage of
the construction of FIG. 21 is that pressure applied to the
pressure chamber 2016 does not easily peel the bond 2114 away from
the pressure jacket 2012 or the inner wall 2102.
[0174] FIG. 22 illustrates a cross-sectional side view of the
distal end of a re-collapsible introducer or sheath 2200 that
includes the outer pressure jacket 2012, the pressure chamber 2016,
the sheath central lumen 2010, the sheath inner wall 2102, the
sheath outer wall 2104, the sheath reinforcement 2106, a distal
pressure jacket bond 2202, and a distal pressure jacket fold
2204.
[0175] Referring to FIG. 22, the outer pressure jacket 2012 can be
folded, at 2204, over the distal end of the sheath outer wall 2104
and sheath inner wall 2102 and welded or otherwise coupled between
the sheath inner wall 2102 and the sheath outer wall 2104. The
sheath inner wall 2102 and the sheath outer wall 2104 can be fused
or welded together with the sheath reinforcement 2106 embedded
therein. An advantage of this construction of the pressure jacket
bond 2202 is that pressure can be applied to the sheath wall
structure 2102, 2104, 2106 all the way to the distal end to force
collapse or refolding wherein the embodiment shown in FIG. 20 can
include a bond region that cannot be pressurized or collapsed
completely. Another advantage of the construction of FIG. 22 is
that pressure applied to the pressure chamber 2016 does not easily
peel the bond 2202 away from the pressure jacket 2012 or the sheath
walls 2102 and 2104. The distal pressure jacket bond 2202 can be
located distally to the distal extent of the sheath reinforcement
2106 in the illustrated embodiment, although some overlap may be
beneficial.
[0176] FIG. 23 illustrates a cross-sectional side view of the
distal end of a re-collapsible introducer or sheath 2300 that
includes the outer pressure jacket 2012, the pressure chamber 2016,
the sheath central lumen 2010, the sheath inner wall 2102, the
sheath outer wall 2104, the sheath reinforcement 2106, a distal
pressure jacket bond 2302, and a distal pressure jacket fold
2304.
[0177] Referring to FIG. 23, the outer pressure jacket 2012 can be
folded, at 2304, distal to the distal end of the sheath outer wall
2104 and sheath inner wall 2102 and welded or otherwise coupled to
the sheath outer wall 2104. Advantageously, the pressure jacket
bond 2302 can allow pressure to be applied to the sheath wall
structure 2102, 2104, 2106 all the way to, and beyond, the distal
end to force collapse or refolding, whereas the embodiment shown in
FIG. 20 can include the bond region 2018 that may not be
pressurized or collapsed completely. Another advantage of the
construction of FIG. 23 is that pressure applied to the pressure
chamber 2016 does not easily peel the bond 2302 away from the
pressure jacket 2012 or the sheath wall 2104. The distal pressure
jacket fold 2304 can be created by forming the distal pressure
jacket bond 2302 and then everting the pressure jacket 2012
proximally and pulling the pressure jacket over the outer sheath
wall 2104. Similar construction techniques can be used in the
embodiments shown in FIGS. 21 and 22.
[0178] FIG. 24 illustrates a cross-sectional side view of the
distal end of the re-collapsible introducer of FIG. 20, detailing
how the outer pressure jacket 2012 can be welded to the exterior of
the sheath wall 2008. The sheath 2000 includes the pressure jacket
2012, the pressure chamber 2016, the sheath central lumen 2010, the
sheath inner wall 2102, the sheath outer wall 2104, the sheath
reinforcement 2106, and the distal pressure jacket bond 2018.
[0179] Referring to FIG. 24, the pressure chamber 2016 does not
extend all the way to the distal end of the sheath. This
construction can be somewhat simpler than that of FIGS. 21-23 but
can result in reduced strength of the distal pressure jacket bond
2018 due to peeling of the pressure jacket from the sheath outer
wall 2104 when the pressure chamber 2016 is pressurized with fluid
such as, but not limited to, saline, radiopaque contrast media, a
combination thereof, or the like. Pressurization beneficial to
collapse the sheath wall 2008 can range from about 1 to about 20
atmospheres with a preferred range of about 2 to about 10
atmospheres.
[0180] FIG. 25A illustrates a cross-sectional partial breakaway
side view of a re-collapsible introducer 2500, including an
uninflated side collapse balloon 2504, further including a distal
collapse balloon bond 2518 and a pressure chamber 2516, sandwiched
between the sheath wall 2008 and an outer pressure jacket 2512,
with the sheath wall 2008 fully expanded. The introducer 2500 also
includes the sheath hub 2002, the sheath central lumen 2010, the
collapse port 2004, a proximal non-expandable region 2510, and a
transition zone 2502.
[0181] Referring to FIG. 25A, the sheath central lumen 2010 can be
in the fully expanded maximum size configuration suitable for
introduction or withdrawal of instrumentation such as catheters,
heart valves, stent-grafts, or the like, therethrough. The pressure
chamber 2516 can be operably and fluidically connected to the
collapse port 2004. The pressure jacket 2512 can be open at the
distal end or it can be closed. The pressure jacket 2512 can be
coupled to the sheath wall 2008 at the distal end or at locations
along the length to facilitate reduction in size when the sheath
wall 2008 and the side collapse balloon 2504 is evacuated.
[0182] FIG. 25B illustrates a cross-sectional partial breakaway
side view of the re-collapsible introducer 2500 of FIG. 25A with
the side collapse balloon 2504 in the expanded, pressurized state.
The introducer 2500 includes the inflated side collapse balloon
2504 further including the distal collapse balloon bond 2518 and
the pressure chamber 2516, sandwiched between the sheath wall 2008
and the outer pressure jacket 2512 with the sheath wall 2008 now
collapsed in the region distal to the transition zone 2502.
[0183] Referring to FIG. 25B, expansion of the side balloon 2504
can force the sheath wall 2008 to fold and compress away from the
outer pressure jacket 2512. The proximal non-expandable region 2510
can also be non-collapsible and does not deform upon application of
pressure within the pressure chamber 2516. The side balloon 2504
need be disposed only in the region where the sheath 2500 is
collapsible, that is, distal to the transition zone 2502. The side
balloon 2504 can be operably connected to the collapse port 2004
with a length of tubing or an annulus, or the side balloon 2504 can
extend all the way to the proximal side balloon bond 2520. An
advantage of this type of collapse mechanism rather than that
illustrated in FIG. 20 can be that the sheath wall 2008 is
compressed into a "U" shape with a smaller overall cross-sectional
profile rather than a more flattened shape.
[0184] FIG. 25C illustrates a cross-sectional side view of the
re-collapsible introducer 2500 of FIG. 25B wherein the side balloon
2504 can be evacuated thus drawing down the exterior of the side
balloon 2504 and the pressure jacket 2512 toward the collapsed
sheath wall 2008 to form a low-profile sheath suitable for removal
from a patient's vasculature. The introducer 2500 includes the
inflated side collapse balloon 2504 further including the distal
collapse balloon bond 2518 and the pressure chamber 2516,
sandwiched between the sheath wall 2008 and the outer pressure
jacket 2512, with the sheath wall 2008 now collapsed in the region
distal to the transition zone 2502.
[0185] FIG. 26A illustrates a cross-sectional side view of a
re-collapsible introducer 2600 wherein the side collapse balloon
2504 can be formed continuously, without a weld or bond at the
distal end. The introducer 2600 includes the sheath hub and the
uninflated side collapse balloon 2504. The side collapse balloon
2504 further includes a distal collapse balloon closed end 2602 and
a pressure chamber 2516, which can be sandwiched between the sheath
wall 2008 and the outer pressure jacket 2512, with the sheath wall
2008 fully expanded. The introducer 2600 also includes the sheath
hub 2002, the sheath central lumen 2010, and the collapse port
2004.
[0186] Referring to FIG. 26A, the illustrated embodiment can be
similar to that shown in FIGS. 25A through 25C, however, the side
collapse balloon 2504 can have the closed distal end 2602 rather
than a weld or bond at the distal end. The side collapse balloon
2504 can extend substantially even with or beyond the distal end of
the sheath tubing wall 2008. This type of closed distal end 2602
can be fabricated using stretch blow molding to expand a billet, or
pre-form, that can be closed at the distal end.
[0187] FIG. 26B illustrates a cross-sectional side view of a
re-collapsible introducer 2650 wherein the side collapse balloon
2612 can be twice as long as the expandable part of the sheath wall
2008 and can include a fold 2606 at the distal end of the sheath to
form a double balloon 2612 stacked radially away from the axis of
the sheath. The double balloon 2612 can be coupled at the proximal
end to the sheath tubing 2008 or the sheath hub 2002. One of the
two proximal ends of the double balloon 2612 can be closed with
seal 2614 to prevent fluid escape and the other proximal end seal
2514 can be coupled and operably connected to the collapse port
2004 by adhesive welding, heat welding, ultrasonic welding, or the
like. Fluid injected or withdrawn through the collapse port 2004
can enter or leave the double pressure chamber 2604. The pressure
jacket can surround the sheath wall 2008 and the double balloon
2612 and can be coupled to any structures that are convenient using
adhesives, mechanical fixation, or the like. Expansion of the
double balloon can compress the sheath wall 2008 and can
beneficially provide more precise shape control of the collapsed
sheath wall 2008 as well as eliminate the seal at the distal end of
the collapse side balloon 2504 of FIGS. 25A-C.
[0188] FIG. 27A illustrates a cross-sectional end view of the
distal, collapsible end of the sheath 2000, as illustrated in FIG.
20, that is fully expanded. The sheath includes the sheath wall
2008, the outer pressure jacket 2012, the pressure chamber 2016,
the malleable reinforcement 2106, and the sheath central lumen
2010.
[0189] FIG. 27B illustrates a cross-sectional end view of the
distal, collapsible end of the sheath 2000 of FIG. 27A, wherein the
pressure chamber or region 2016 between the outer pressure jacket
2012 and the sheath wall 2008 has been pressurized to collapse the
sheath wall 2008 and the malleable reinforcement 2106. The shape of
the cross-section can be a flattened, curved structure that can be
larger in a lateral dimension than the expanded sheath of FIG. 27A
but can have lower overall contact with a blood vessel (not shown).
The central sheath lumen 2010 can be distorted and collapsed.
[0190] FIG. 27C illustrates a cross-sectional end view of the
distal, collapsible end of the sheath of FIG. 27A and 27B wherein
the pressure chamber, or region 2016, between the outer pressure
jacket 2012 and the sheath wall 2008 has been evacuated to collapse
the outer pressure jacket 2012 and resultant sheath exterior.
[0191] FIG. 28A illustrates a cross-sectional end view of the
distal, collapsible end of a fully expanded sheath 2500 that can
include the sheath wall 2008, the side-balloon 2504 further
including the pressure chamber 2516, the central lumen 2010, and
the outer pressure jacket 2512. The sheath wall 2008 can be fully
expanded revealing a maximum sized sheath central lumen 2010. The
side balloon 2504, sandwiched between the pressure jacket 2512 and
the sheath wall 2008 on one side, can be collapsed and can include
a minimized pressure chamber 2516. In some embodiments, one side
balloon 2504 can be used. In some embodiments, up to four side
balloons 2504 or more can be used.
[0192] FIG. 28B illustrates a cross-sectional end view of the
distal, collapsible end of the sheath 2500 of FIG. 28A, wherein the
pressure chamber 2516 of the side-balloon 2504 is pressurized and
expanded to collapse the sheath wall 2008 away from the pressure
jacket 2512, and into an arcuate or "U" shape with a smaller
cross-sectional area than illustrated in FIG. 28A.
[0193] FIG. 28C illustrates a cross-sectional end view of the
distal, collapsible end of the sheath 2500 of FIGS. 28A and 28B,
wherein the pressure chamber 2516 within the side-balloon 2504 has
been evacuated and collapsed against the sheath wall 2008. The
pressure jacket 2512 can remain large and the region 2802 between
the pressure jacket 2512 and the sheath wall 2008 can remain large.
In some embodiments, adhesives, welds, fasteners, or the like can
be used to maintain the pressure jacket 2512 adjacent to the sheath
wall 2008.
[0194] FIG. 28D illustrates a cross-sectional end view of the
distal, collapsible end of the sheath 2500 of FIG. 28C, wherein the
region 2802 between the side-balloon 2504 and the pressure jacket
2512 has been evacuated, causing the pressure jacket 2512 to
collapse against the side balloon 2504, thus minimizing the profile
of the system.
[0195] FIG. 29 illustrates a partial breakaway side view of a
sheath hub 2002 and the internal components that can provide for
hemostasis during and following introduction of catheters or
instruments therethrough. The sheath hub 2002 can include a hub
cavity 2902, a hub cap 2914, a thin spacer 2912, a plurality of
pinhole valves 2910, a wide spacer 2908, a pinhole slit disc 2904,
and a cross-slit valve 2906.
[0196] Referring to FIG. 29, the sheath hub 2002 can be fabricated
from substantially rigid materials such as, but not limited to,
polycarbonate, polysulfone, ABS, or the like. The pinhole valves
2910, the cross slit valve 2906, and the pinhole slit disc 2904 can
be fabricated from elastomeric polymers such as, but not limited
to, silicone elastomer, latex, polyester elastomers, nylon
elastomers, polyurethane elastomers, or the like. Hardness ranges
for the elastomers can range between about 10 A and 65 A, with a
preferred range of about 30 A and 50 A. In some embodiments, the
pinhole valves 2901 can be separated from the pinhole slit valve
2904 by the wide spacer 2908. The thin spacer 2912 can serve as a
washer to prevent distortion of the elastomeric pinhole valves
2910, when the hub cap 2914 can be threaded into place at the
proximal end of the sheath hub 2002.
[0197] The cross-slit valve 2906 can serve to close off the system
from blood leakage at systemic arterial pressures when nothing is
inserted through the system. The pinhole slit valve or disc 2904
can close against and provide hemostasis for a guidewire having a
diameter of about 0.010 to about 0.040 inches diameter following
removal of large catheters (up to 26 French or larger). The pinhole
valves 2910 can seal against blood leakage prior to a catheter
having been introduced through the system. The pinhole valves 2910
can include a central hole having a diameter of about 0.010 to
about 0.030 inches with a preferred range of about 0.018 to 0.025
inches diameter. The pinhole valves 2910 can also serve to center a
guidewire (not shown) so that it remains properly aligned within
the hole at the center of the pinhole slit disc 2904. The slit in
the pinhole slit valve 2904 can have no width, but can have a
length ranging from about 2 mm to about 15 mm.
[0198] The internal components of the sheath hub 2002 can be
assembled with substantially no longitudinal distance between each
part to maximize stability and controllability of the valve seal.
The pinhole slit valve 2904, in the illustrated embodiment can
include a double convex center with the center thickness dimension
greater than the thickness dimension at a more radially outward
location, excluding the mounting flange on the extreme exterior of
the pinhole slit valve 2904. The central hole, having a diameter of
about 0.020 to 0.035 inches, can beneficially include a fillet or
chamfer on the proximal side to facilitate inserting guidewires and
catheters therethrough. In some embodiments, it may be beneficial
to fabricate the pinhole valves 2910 from different hardness
materials. For example, the more distal pinhole vale 2910 can have
a hardness of 50 A while the proximal pinhole valve 2910 can have a
hardness of 35 A. This latter embodiment can provide for improved
seal following long-term placement of a dilator through the valve
relative to a system using only 35 A pinhole valves 2910.
[0199] The hub cap 2914 can include a central orifice that can
taper inward as the cap 2914 extends distally to help guide
catheters inserted therethrough toward the center. The central hole
can further provide limitation to prevent too large a catheter from
being inserted therethrough.
[0200] FIG. 30 illustrates cross-sectional side views of
alternative embodiments of the components within the sheath hub
2002. The sheath hub 2002 can include the hub cavity 2902, which
can be an axially elongate inner void defined by the walls of the
sheath hub 202. FIG. 30 differs from FIG. 29 in that the pinhole
valves 2910 and the pinhole slit valve 2904 can be replaced with
alternate valve mechanisms. The 2910 pinhole valves, of which there
can be two, can be replaced by a single double convex elastomeric
valve 3002. The double convex elastomeric valve can include the
central orifice 3004 and the outside flange 3006. The pinhole slit
valve 2904 can be replaced by a conical taper valve 3010 further
including a central orifice 3012, a slit 3014, and an exterior
flange 3016. Both valves 3002 and 3010 can be fabricated from the
same materials as used in fabricating the elastomeric valves of
FIG. 29. The double convex elastomeric valve orifice 3004 can have
a diameter of about 0.010 to 0.035 inches. The conical valve 3010
includes a similar diameter central hole 3012 as that of the double
convex valve 3002. These valves can feature tapers to guide
catheters therethrough and substantial material masses to control
the size of the central orifices. The components 3002 and 3010 can
be sandwiched tightly within the valve body 2002 with little or no
axial spacing therebetweeen. The use of the double convex valve
3002 or the conical pinhole slit valve 3010 can be interchanged or
mixed to maximize sheath hub function.
[0201] It should be noted that certain objects and advantages of
the invention have been described above for the purpose of
describing the invention and the advantages achieved over the prior
art. Of course, it is to be understood that not necessarily all
such objects or advantages may be achieved in accordance with any
particular embodiment of the invention. Thus, for example, those
skilled in the art will recognize that the invention may be
embodied or carried out in a manner that achieves or optimizes one
advantage or group of advantages as taught herein without
necessarily achieving other objects or advantages as may be taught
or suggested herein.
[0202] Moreover, although this invention has been disclosed in the
context of certain preferred embodiments and examples, it will be
understood by those skilled in the art that the present invention
extends beyond the specifically disclosed embodiments to other
alternative embodiments and/or uses of the invention and obvious
modifications and equivalents thereof. In addition, while a number
of variations of the invention have been shown and described in
detail, other modifications, which are within the scope of this
invention, will be readily apparent to those of skill in the art
based upon this disclosure. For example, it can be contemplated
that various combination or subcombinations of the specific
features and aspects of the embodiments may be made and still fall
within the scope of the invention. Accordingly, it should be
understood that various features and aspects of the disclosed
embodiments can be combined with or substituted for one another in
order to form varying modes of the disclosed invention. Thus, it is
intended that the scope of the present invention herein disclosed
should not be limited by the particular disclosed embodiments
described above, but should be determined only by a fair reading of
the claims that follow.
* * * * *